Recurring concern

Failure to ensure clear and followed instructions for safe equipment use

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First reported 15 Dec 2015•Latest report 31 Mar 2026

Definition

What this concern includes

Includes failures of controls specifically dedicated to safe equipment-use instructions, including provision, availability, clarity, completeness, identification of defect or hazard indications, user understanding, and monitoring or assurance of compliance, across clinical, industrial, recreational and other operational equipment.

Not included

  • Excludes generic training, supervision, documentation or compliance deficiencies that are not specifically tied to safe equipment-use instructions.
  • Excludes equipment defects, maintenance or certification failures where no instruction or instruction-compliance control is deficient.
  • Excludes clinical, referral, care or operational protocols that do not govern the safe use of equipment.
  • Excludes failures concerning the operation of a particular piece of equipment when the report does not identify an equipment-use instruction or compliance-control deficiency.
Reports
22

Distinct published reports

Individual concerns
26

A report can raise multiple concerns

Date range
2015–2026

First to latest report issue date

Stated actions
53

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care3
Medicines and Healthcare products Regulatory Agency3
NHS England3
Abbeyfield The Dales Limited1
Agd Equipment Limited1
Birmingham City Council1
Boc Limited1
British Standards Institution1
Broomcroft House Care Home1
Bupa Care Homes (AKW) Limited1
Bureau Veritas UK Limited1
Care Quality Commission1
Civil Aviation Authority1
Construction Plant-hire Association1
Department for Work and Pensions1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Newcastle upon Tyne and North Tyneside

    AI-generated summary

    David Michael O’Brien · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    David Michael O’Brien died at North Tyneside General Hospital after falling from his wheelchair, sustaining a hip fracture, and developing bronchopneumonia. Concerns included excessive wheelchair use despite advice that it was for mobility only, inadequate communication and record keeping between care providers, failure to undertake a risk assessment, and advice about the wheelchair not being followed.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to restrict wheelchair use to mobility when no safe alternative seating was available

    Wider context from the report

    “1. I heard evidence from Springfield Health Care Services that Mr O’Brien was using his wheelchair throughout the day and was either in bed or transferred to his wheelchair with nowhere else for him to safely sit. This excessive use was contrary to advice from Wheelchair Services, who had advised that the wheelchair was only to be used as a mobility aid. ”

    Source location

    David Michael O’Brien · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to follow mobility-only wheelchair advice and provide safe general seating

    Wider context from the report

    “5. Evidence from Wheelchair Services was that an assessment of the wheelchair took place in Mr O’Brien’s home on 20.12.19. Mr O’Brien and one of his regular carers from Springfield Health Care were present. His seatbelt was tightened and advice was given by Wheelchair Services that the wheelchair was only for use to mobilise and not for general seating. Notwithstanding this advice, Mr O’Brien continued to use the wheelchair throughout the day as his only seating option and was assisted into it by hoist by his carers. ”

    Source location

    David Michael O’Brien · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    There were no reasonable grounds to suspect an offence under Regulations 12 and 22, so formal criminal investigation was not undertaken.

    Verbatim wording from the response

    “The second took place after the inquest and took account of the evidence gathered during the coronial investigation and specifically the concerns raised at points 1-8 of your Regulation 28 report. In both cases the CQC concluded there were no reasonable grounds to suspect an offence under Regulations 12 and 22 RAR 2014 and no formal criminal investigation was undertaken.”

    Source location

    2022-0068-Response-from-CQC_Published
    Page 2 · response
    Published 8 March 2022

    Open published response
  2. North Yorkshire (Western)

    AI-generated summary

    Dorothy Pegg · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Dorothy Pegg slipped from a shower chair while sitting on a sling and suffered bilateral leg fractures, which contributed to her death. The report identified concerns about the absence of monitoring for compliance with equipment-use instructions and the lack of instructions about when specific prescribed equipment should be used.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of instructions on the circumstances for using specific prescribed equipment

    Wider context from the report

    “2. There were no instructions as to the circumstances in which it is appropriate that specific prescribed equipment is used. ”

    Source location

    Dorothy Pegg · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of monitoring of compliance with equipment-use instructions

    Wider context from the report

    “1. There was no system of monitoring the compliance with instructions as to how equipment should be used. ”

    Source location

    Dorothy Pegg · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Use the new care plan format to document mobility equipment, operating procedures and equipment changes, with monthly completeness and accuracy checks.

    Verbatim wording from the response

    “New Care Plan Format (already introduced) The statement I provided to the coroner contained details of the new care plan format introduced across all sites during 2020. In the new care plan format (section 6 – Mobility, Fitness and Falls Prevention) the documentation contains an image of all equipment used to support a resident’s mobility. This section is updated by either the Senior Carer, Assistant Manager of Registered Manager if the equipment used is changed or discontinued. The mobility section of a resident’s care plan also documents systems of work (a standard operating procedure) for all equipment used.”

    Source location

    2021-0358-Response-from-Abbeyfield-The-Dales-Ltd_Published
    Page 1 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Record new mobility equipment, images and correct-use instructions in residents’ care plans, including instructions supplied by health professionals.

    Verbatim wording from the response

    “New Equipment (already introduced) A record of new equipment delivered to support a resident’s mobility (a delivery note) is held in a resident’s care plan (where one is received). The care plan is updated with an image of the equipment, so it is clear what equipment must be used when supporting a resident with their mobility and clear instructions are set out in the care plan regarding the correct use of the equipment.”

    Source location

    2021-0358-Response-from-Abbeyfield-The-Dales-Ltd_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Implement a process clarifying new equipment use, circumstances, staff accountability and competency checks for equipment introduced by health professionals.

    Verbatim wording from the response

    “New Equipment Process (to be implemented in January 2022) We have developed a process to ensure staff are clear of the correct use for and operation of a new piece of equipment that is introduced by an Occupational Therapist or other Health Professional to support the safe transfer and movement of a resident. This process is intended to ensure there is no ambiguity in how and in what circumstances a piece of equipment is used, and also there is clear accountability and checking that staff are knowledgeable and confident in the use of the equipment to support that resident. Please see a blank version of the process at appendix 4.”

    Source location

    2021-0358-Response-from-Abbeyfield-The-Dales-Ltd_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Revise moving-and-handling assessment templates to identify the assessed equipment task and require advice before use outside that scope.

    Verbatim wording from the response

    “➢ NYCC will change moving and handling risk assessment and plan templates to have a descriptor box at the top to clearly identify the task for which the equipment has been assessed and provided for by the OT. There will also be a point of note that if the equipment is to be used outside this scope, advice should be sought by the care provider from an appropriately trained person. The updated template will be uploaded to NYCC’s case recording system (LLA) and is to be used as from 31 January 2022.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Use the revised templates in NYCC’s case-recording system and remind occupational therapists to adopt them.

    Verbatim wording from the response

    “➢ NYCC will change moving and handling risk assessment and plan templates to have a descriptor box at the top to clearly identify the task for which the equipment has been assessed and provided for by the OT. There will also be a point of note that if the equipment is to be used outside this scope, advice should be sought by the care provider from an appropriately trained person. The updated template will be uploaded to NYCC’s case recording system (LLA) and is to be used as from 31 January 2022.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Use a practice review meeting to reinforce clarity about the intended task when moving-and-handling plans are completed and shared.

    Verbatim wording from the response

    “➢ An agenda item was included in a NYCC Practice Review meeting on 29th November 2021 and attended by OT Team Managers, Senior OTs and Training & Learning representatives to ensure that when moving and transferring plans are completed and shared with the person and/or their carers, these include clarity on the task for which equipment is intended. When the revised moving and handling risk assessment and plan templates are uploaded onto NYCC’s case recording system, a reminder will be sent to all OTs to use the new template forms.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Notify equipment prescribers through the ICES newsletter about the new moving-and-handling templates.

    Verbatim wording from the response

    “➢ There are a range of roles across the NHS and Local Authority that can prescribe equipment including physiotherapists and OT’s. The Integrated Community Equipment Service (ICES) is a jointly funded service between the NHS and Local Authority and will alert prescribers of equipment to the new moving and handling document through a newsletter. A notification is sent to each user of the ICES to make them aware of the newsletter which includes equipment updates and alerts. The next newsletter is scheduled for early 2022 and will contain an article to introduce the new templates. A prompt is included in the Equipment Request Form on the ICES database as a reminder to non-NYCC prescribers to complete a moving and handling risk assessment and plan. A quarterly dip sample audit of the Equipment Request Form will be completed to monitor compliance with the new arrangement.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Require care-provider contracts to specify that prescribed equipment is used for its assessed purpose and that changes are reflected in care plans.

    Verbatim wording from the response

    “➢ NYCC will ensure that contracts with care providers have reference within the terms and conditions that any equipment prescribed is used for the assessed purpose. NYCC will also ensure that any change to provision or use is to be incorporated and updated by providers within their care plans. These actions will be achieved by 31 March 2022.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Share and reinforce correct equipment, moving-and-handling-plan, and care-plan practices through care-provider forums, bulletins, and online events.

    Verbatim wording from the response

    “➢ NYCC will utilise its care provider forums to share and reinforce correct practice (for example, around moving and handling plans always accompanying relevant equipment provision) and to share practice around care plans being updated at any equipment change. We propose to share such information via NYCC’s provider forums, provider bulletins and Care Connected (a regular online provider event). These actions will be achieved by 31 March 2022.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Reinforce with ICES the contractual requirement to supply equipment with instruction leaflets.

    Verbatim wording from the response

    “➢ NYCC have reminded ICES of the contractual requirement to deliver all equipment accompanied by an instruction leaflet. This requirement was included as an agenda item in The Vale of York’s (as lead commissioner) Performance and Quality meeting on 25 November 2021 attended by NHS and Local Authority commissioners and representatives from ICES. Following the meeting the contractual requirement was reiterated via an email from OT Lead for the Local Authority to ICES.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Request that ICES make equipment instruction leaflets retrievable from its database for occupational therapists.

    Verbatim wording from the response

    “➢ In addition to the above, on 25 November 2021, NYCC has requested ICES to provide instruction leaflets for equipment on the equipment database for retrieval by Occupational Therapists to accompany moving and handling risk assessment and plans. This request has been followed up via email with ICES who have confirmed that work will start on this week commencing 20th December 2021.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Introduce dedicated occupational-therapy training on completing moving-and-handling assessments and plans, incorporating learning from the inquest.

    Verbatim wording from the response

    “➢ Future training for new or existing OTs is to include a dedicated module with examples and scenarios for completing moving and handling risk assessments and plans. The learning from”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Deliver specialist moving-and-handling training for NYCC occupational therapists focused on equipment purpose and moving-and-handling plans.

    Verbatim wording from the response

    “➢ A specialist moving and handling training event for NYCC OTs is scheduled for February and March 2022 and will incorporate a specific focus on instructions as to the purpose of equipment and moving and handling plans.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 3 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct unannounced Quality Manager spot-check audits of care plans and observed care practice to verify compliance with equipment-use instructions and address improvements.

    Verbatim wording from the response

    “Quality Manager Spot Check Audits (re-introduced in 2021) Part of the Quality Manager’s role is to provide audit assurance to the Registered Manager and Senior Leaders of Abbeyfield The Dales that care delivery and record keeping is in line with policy and best practice. This includes ensuring carers comply with instructions as to how/what”

    Source location

    2021-0358-Response-from-Abbeyfield-The-Dales-Ltd_Published
    Page 1 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct standardized service delivery audits comparing care delivered with care plans, and follow up deficiencies through supervision, retraining or closer performance monitoring.

    Verbatim wording from the response

    “Service Delivery Audit (launched with Managers in September 2021) The service delivery audit has recently been introduced and standardises a variety of formats and content of similar audits that have been in use up until recently. The audit checks that the service delivered by a member of the care team is in line with what is required in the care plan, and expected from an Abbeyfield The Dales employee. Please see a blank version of the form at appendix 3.”

    Source location

    2021-0358-Response-from-Abbeyfield-The-Dales-Ltd_Published
    Page 2 · response
    Published 1 November 2021

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Monitoring compliance with equipment-use instructions is assigned to Abbeyfields the Dales rather than North Yorkshire County Council.

    Verbatim wording from the response

    “1. There was no system of monitoring the compliance with instructions as to how equipment should be used.”

    Source location

    2021-0358-Response-from-North-Yorkshire-County-Council_Published
    Page 1 · response
    Published 1 November 2021

    Open published response
  3. West Yorkshire Eastern

    AI-generated summary

    Kenneth Audsley · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Kenneth Audsley, an experienced high-voltage electrical engineer aged 56, was overcome by carbon monoxide while investigating a fault inside an industrial transformer at work. The transformer contained substantially less oil than it should have, allowing carbon monoxide to accumulate. Concerns included insufficient awareness of the risk, a lack of warning signs and manufacturer warnings, no recommended periodic maintenance regime, and the possibility that other transformers could pose comparable risks.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of transformer warning signage requiring confirmation of adequate oil before use

    Wider context from the report

    “(2) There were no warning signs affixed to the transformer alerting users to the risk of using the transformer unless it had first been confirmed it contained adequate oil. ”

    Source location

    Kenneth Audsley · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Attach prominent oil-level and carbon-monoxide warning stickers to all transformers, instructing users not to energise without sufficient oil.

    Verbatim wording from the response

    “Secondly, we have now attached stickers to all of our transformers as per your suggestion, providing a reminder to third-party operators not to energise transformers without first ensuring there is sufficient oil inside. Please see the images below.”

    Source location

    2021-0303-Response-from-Hirst-Electrical_Published
    Page 1 · response
    Published 17 September 2021

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The company considers its documented transformer safety changes sufficient to satisfy the notice and does not identify further necessary work.

    Verbatim wording from the response

    “We trust the aforementioned is sufficient action to satisfy the notice. However, if you believe there is more we can do then we welcome any further suggestions.”

    Source location

    2021-0303-Response-from-Hirst-Electrical_Published
    Page 3 · response
    Published 17 September 2021

    Open published response
  4. Wiltshire and Swindon

    AI-generated summary

    Flt. Lt. Alexandre Jay Parr · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Flt. Lt. Alexandre Jay Parr died after fuel starvation caused loss of engine power during a training flight in a Yak 52 aircraft, followed by a forced landing and crash on 8 July 2016. The report identified concerns about engine-overhaul limits, aircraft safety harnesses, and communicating the appropriate emergency use cycle rate for the fuel primer pump to Yak pilots.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of the emergency fuel-primer-pump instructions to specify the required cycle rate

    Wider context from the report

    “c) THE USE OF THE FUEL PRIMER PUMP IN AN EMERGENCY. Whilst the primer pump may not have originally been specifically designed for use in an emergency I understand from the AAIB investigators that the manufacturer's state in their manual that the pump can be used in an emergency, for example should the fuel pump fail. Regrettably, I also understand that the manufacturer's manual gives no indication as regards the cycle rate for the use of the primer pump in these emergency circumstances. When G-YAKB experienced a loss of engine power and Alex sitting in the front cockpit used the primer pump he was pumping at a rate of 1 cycle every 3 to 4 seconds. This was found to be insufficient to provide sufficient fuel to the engine in order to regain power. When the AAIB investigators attempted to ascertain a sufficient cycle rate they found that a significantly higher rate was required in order to provide sufficient fuel to the engine. That rate was 1.3 cycles per second. I am unclear, aside from the findings of the AAIB report, as to how this potentially important piece of information can be communicated to the YAK user population in the United Kingdom. It seems to me that this information is important and may be unknown to many YAK pilots and I am concerned that if the intention is that YAK 52 pilots are required to read this AAIB Report concerning this incident, then this particular piece of information may be missed if a pilot does not research this particular incident. I would respectfully ask you to consider how best to communicate this information to the wider YAK pilot community in the United Kingdom. ”

    Source location

    Flt. Lt. Alexandre Jay Parr · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Discuss YAK fuel-primer-pump use during power loss at the next CAA-led YAK and Nanchang Continuing Airworthiness Forum and consider whether additional UK guidance would be useful and effective.

    Verbatim wording from the response

    “manufacturer to specify a rate. The use of the YAK Fuel Primer Pump in the event of a loss of power, will be included for discussion at the next CAA led YAK & Nanchang ‘Continuing Airworthiness Forum’ due to be held by the end of the second quarter of 2019 and attended by key owners and maintainers of the affected types. The Group will consider whether additional guidance to UK users would be useful and effective.”

    Source location

    2019-0001-Response-by-CAA
    Page 3 · response
    Published 23 May 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Requesting the manufacturer to specify a fuel-primer-pump rate is not appropriate because technical and human factors may make use counterproductive.

    Verbatim wording from the response

    “The CAA has established there are a number of different technical and human factors that would have an impact on the effectiveness of utilisation of the Fuel Primer Pump, particularly in emergency situations where it’s use may, in certain circumstances be counter-productive. For this reason, the CAA has concluded it would not be appropriate for CAA to request the”

    Source location

    2019-0001-Response-by-CAA
    Page 2 · response
    Published 23 May 2019

    Open published response
  5. North Northumberland

    AI-generated summary

    Maurice Leslie Wrightson · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Maurice Leslie Wrightson, a coach driver, died in France on 16 April 2013 after the brakes on his coach stopped responding during a mountain descent; the coach crashed into rocks and burst into flames. The principal concern was that Volvo vehicle manuals did not adequately explain the risks of using automatic gearbox mode during long downhill descents, creating uncertainty and a potential risk of future deaths.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of manufacturer guidance on automatic gearbox use during long downhill descents

    Wider context from the report

    “During the hearing evidence was heard that Mr Wrightson was using i-shift automatic gears while driving the coach, and a foot retarder, in addition to the normal vehicle brakes during the long mountain descent. The inquest heard from a former Depot Manager ████████ that following Mr Wrightson’s death, he checked with other coach drivers in the employment of Classic Coaches, Durham, at the time, as to their usual driving practice and found that their driving practices were equally divided. Some drivers engaged manual gears and others used automatic i-shift gears during mountain descents. Mr Shipley took the decision to instruct all drivers to use manual gears during long mountain descents. Evidence was heard that driving uphill, an automatic gear system works on the principle of climbing with a low gear initially until the vehicle gains momentum and automatically steps up to the next gear as resistance lowers and speed increases. Conversely, going downhill the use of automatic gears would have less resistance and increased momentum, causing a need for additional braking. ████████ informed the inquest that he had tried to clarify the position with Volvo as to the recommendations contained in the Vehicle Manual, which gave a clear recommendation as to the use of vehicle gears while going uphill but was silent as to any recommendation when going downhill. ████████ said that in attempting to clarify the situation with the vehicle manufacturers, the reply he received was that drivers ‘should follow the information or advice contained in the Vehicle Manual’. The manufacturers (Volvo) had not been recognised as an interested person or invited to attend the Inquest because this was a point which arose during the hearing of ████████ evidence at the Inquest itself. ████████ evidence was that the Volvo handbook wallet for the B12B and B12M produced in 2004 has a driver’s handbook, operating instructions display booklet, operating instructions EBS booklet and operating instructions I-shift gearbox booklet which gives guidance only in relation to driving up a hill and the locking gear. In respect of subsequent Volvo models the advice remains the same except that later dated manuals advise ‘caution in respect of brake fade in long descents’. There is no warning that automatic mode is likely to exacerbate brake fade in long descents (such as at Alp D’Huez). ████████ told the inquest that he would at that time, as a PCV driver himself, have done exactly the same as Maurice Wrightson and used automatic mode. The Volvo manual gives no guidance to drivers for downhill driving such that automatic gearbox mode would be selected rather than manual by most drivers. Owners and drivers are reliant on the manufacturer to supply adequate instructions on the use of these technological advancements fitted to their vehicles. The inquest does not apportion any blame or liability for the circumstances of deaths and is prevented by Sections 5 and 10 of the Coroners and Justice Act 2009 from doing so. However, it seems to me that the lack of information contained in the Vehicle Manual may lead to a lack of understanding or uncertainty, and there is a risk that this may lead to future deaths. ”

    Source location

    Maurice Leslie Wrightson · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Automatic gearbox mode is not generally likely to exacerbate brake fade during long descents.

    Verbatim wording from the response

    “Having investigated your concerns thoroughly we do not support a general statement that the use of automatic gear mode is likely to exacerbate brake fade in long descents. It is true that the automatic mode and manual mode both have characteristics which can be different to each other. However these differences can be both positive and negative depending on the characteristic and the circumstance. On balance we do not feel that the differences are sufficient to issue a recommendation in the vehicle manual in favour of one gearbox mode over the other. The correct use of the retarder is much more important than the selection of manual or automatic mode on the gearbox when driving down hills and this is highlighted on page 56 of the current manual which states “Use the retarder function when driving down hills and for slow braking”.”

    Source location

    2017-0372-Response-by-Vovlo-Group-UK-Limited
    Page 1 · response
    Published 11 February 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The current manual's instruction to use the retarder when driving downhill is sufficient; no gearbox-mode recommendation is needed.

    Verbatim wording from the response

    “Having investigated your concerns thoroughly we do not support a general statement that the use of automatic gear mode is likely to exacerbate brake fade in long descents. It is true that the automatic mode and manual mode both have characteristics which can be different to each other. However these differences can be both positive and negative depending on the characteristic and the circumstance. On balance we do not feel that the differences are sufficient to issue a recommendation in the vehicle manual in favour of one gearbox mode over the other. The correct use of the retarder is much more important than the selection of manual or automatic mode on the gearbox when driving down hills and this is highlighted on page 56 of the current manual which states “Use the retarder function when driving down hills and for slow braking”.”

    Source location

    2017-0372-Response-by-Vovlo-Group-UK-Limited
    Page 1 · response
    Published 11 February 2018

    Open published response
  6. Manchester West

    AI-generated summary

    Pauline Hayston · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Pauline Hayston, who had reduced mobility, frailty and recent falls, sustained an unwitnessed fall while attempting to mobilise as an inpatient and later died following a fractured neck of femur and resulting immobility. The concerns identified related to the reliability and fitness for purpose of the Rambledguard falls mats, the suitability of the wireless system when several mats were in use, and the absence of technical instructions for nursing staff about operational problems.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide nursing staff with instructions on the operational integrity of essential falls-risk equipment

    Wider context from the report

    “The evidence raises the following concerns: 1. The reliability of the Rambledguard fall mats and its fitness for purpose. 2. The suitability of a wireless “WiFi” activated where several fall mats are in place in proximity to each other. 3. Insertion of instructions to nursing staff where the operational integrity of an essential equipment to alleviate falls risks has been identified. ”

    Source location

    Pauline Hayston · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  7. Newcastle upon Tyne

    AI-generated summary

    Sheila Mary Hynes · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Sheila Mary Hynes died after an aortic and mitral valve replacement procedure in which a mechanical aortic valve was remounted in an inverted position and re-implanted. The resulting acute heart damage led to her death. Concerns included remounting the valve contrary to the manufacturer’s instructions, inadequate awareness of the associated risks, and directing a scrub nurse without relevant training or experience to remount it.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Remounting of the valve contrary to the manufacturer’s instructions for use

    Wider context from the report

    “(1) During Mrs Hynes operation a direction was given to remount the Sorin Carbomedics 23mm mechanical aortic valve on its holder whilst preparations to implant the valve were undertaken. Remounting the valve on its holder is contrary to the manufacturer’s instructions for use. Concerns arising are: a) The rational for departing from the manufacturer's instructions for use was neither discussed nor recorded. b) The primary surgeon and operating team were unaware of the risks of departing from the manufacturer's instructions for use namely potential inverted remount. c) A scrub nurse with neither training nor experience was instructed to remount the valve contrary to the manufacturer's instructions for use. The rational for this direction was neither discussed nor recorded. d) The primary surgeon with overall responsibility for the procedure did not instruct remounting of the valve; There are no recorded discussions with the primary surgeon on this issue. ”

    Source location

    Sheila Mary Hynes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of awareness among the primary surgeon and operating team of the risks of departing from the manufacturer’s instructions for use

    Wider context from the report

    “(1) During Mrs Hynes operation a direction was given to remount the Sorin Carbomedics 23mm mechanical aortic valve on its holder whilst preparations to implant the valve were undertaken. Remounting the valve on its holder is contrary to the manufacturer’s instructions for use. Concerns arising are: a) The rational for departing from the manufacturer's instructions for use was neither discussed nor recorded. b) The primary surgeon and operating team were unaware of the risks of departing from the manufacturer's instructions for use namely potential inverted remount. c) A scrub nurse with neither training nor experience was instructed to remount the valve contrary to the manufacturer's instructions for use. The rational for this direction was neither discussed nor recorded. d) The primary surgeon with overall responsibility for the procedure did not instruct remounting of the valve; There are no recorded discussions with the primary surgeon on this issue. ”

    Source location

    Sheila Mary Hynes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  8. Cumbria

    AI-generated summary

    Michael Parke · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Michael Parke, who had chronic liver disease, was admitted to West Cumberland Hospital and had a nasogastric tube inserted. The tube was misplaced into his left lung, an x-ray showing this was misinterpreted, and feeding and medication were administered through the tube before he developed aspiration pneumonia and died. The concerns included staff not following nasogastric-tube policy and systemic failures in policy implementation, training, competency checks, auditing and organisational learning.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of ward-based systems to ensure compliance

    Wider context from the report

    “I have now held inquests into 3 deaths as a result of misplaced nasogastric tubes at North Cumbria Hospitals which occurred over a period of a little over 7 years. These types of death are described as ‘Never Events’. On the facts of these three cases the deaths were avoidable. Common themes in all are: (a) Staff not being aware of the policy. (b) Staff not reading the policy. (c) Staff not applying the policy. (d) Staff not following good practice. (e) The Trust not ensuring compliance nor rolling out training to all who needed it. (f) Lack of checks and audits to establish competence and adherence to policy. (g) Failure of the Trust to learn from the first death. (h) Lack of Corporate Memory (the issue of NGTs was not on the Risk Register). (i) The Trust not fully implementing the 2011 NPSA Alert for over two years and only as a result of the second death. (j) Even after the second death not having systems in place to ensure compliance on the ward which contributed to the third death. (k) The Trust Policy growing in size from 20 to 36 pages in 7 years, making it difficult for busy practitioners to absorb (there are some 200 Policies in the Trust). (l) The current Policy has cross-references to paragraphs which do not exist. These errors have been carried through three versions, and raise the risk of misinterpretation by staff and undermining their confidence in such an important document. ”

    Source location

    Michael Parke · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  9. Surrey

    AI-generated summary

    Zane Ilorie Christopher Yusuf GBANGBOLA · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Zane Ilorie Christopher Yusuf GBANGBOLA, aged seven, died on 7 February 2014 after exposure to carbon monoxide from a petrol-driven pump used during severe flooding at his family home. The report raised concerns that HAE safety guidance for internal-combustion-engine equipment used in confined areas was inadequate and potentially misleading, and that the use of HSE branding could be interpreted as endorsement of the guidance.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Inadequacy and inaccuracy of safety guidance for internal-combustion-engine equipment used in confined or enclosed areas

    Wider context from the report

    “I am concerned that the Safety Guidance documents currently prepared by HAE in relation to equipment that is driven by an internal combustion engine, where there is a realistic risk that that equipment might be used in confined areas, are inadequately and potentially misleading. Further, that the use of the HSE logo, in whatever form it might appear, runs the risk of being interpreted by someone reading the document as being an endorsement by the HSE of the document and its contents, thereby exacerbating the potential risk of harm by increasing that person’s confidence in the guidance albeit that the guidance may be poor. a. The adequacy and accuracy of the Safety Guidance documents prepared by HAE for their members, not only in relation to this centrifugal pump, but in relation to any piece of equipment that is powered by an internal combustion engine where there is a realistic prospect that that piece of equipment might be used in an enclosed area. b. The use of the HSE logo on documents that are prepared for general use by trades people and members of the public alike, whether that be the official HSE logo or whether it be in the form of an HSE banner Consideration should be given to taking steps to ensure that the use of any such logo, banner or equivalent representation of the HSE emblem does not give the appearance of the guidance within that document having been endorsed by the HSE when in fact it has not been. ”

    Source location

    Zane Ilorie Christopher Yusuf GBANGBOLA · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report
  10. South Wales Central

    AI-generated summary

    James Michael HEDGE · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    James Michael HEDGE, an 18-year-old type 1 insulin-dependent diabetic, was found deceased in his room at Cardiff University with an insulin pump connected to him. The pump’s insulin cartridge had been fitted incorrectly and leaked, and the inquest recorded diabetic ketoacidosis as the medical cause of death. Concerns included inadequate guidance about the dangers of insulin-pump misuse and insufficient education about the potentially rapid, life-threatening consequences of hyperglycaemia.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Inadequate advice and guidance on insulin pump misuse dangers

    Wider context from the report

    “(1) The evidence showed that the advice and guidance in relation to the use of the insulin pump, which is one of several on the market, does not adequately highlight the dangers of misuse and the potential consequences which may follow if the device is not used correctly – in this case, the incorrect insertion of the insulin cartridge leading to a leak and loss of insulin at a time when blood sugars were high. ”

    Source location

    James Michael HEDGE · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review user manuals and training materials in response to the inquest evidence and identified safety concerns.

    Verbatim wording from the response

    “As a preliminary matter, please be aware that patient safety is our utmost priority. We have therefore carefully reviewed our user manuals and training materials in response to the evidence given at the inquest as well as to your matters of concern. In this response we focus on the Accu-Chek Insight insulin pump system, the pump used by Mr Hedge. However similar information and training is provided in relation to other Roche insulin pumps”

    Source location

    2016-0269-Response-by-Roche-Diabetes-Care-Limited
    Page 1 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Issue and distribute a Field Safety Notice reinforcing correct insulin-cartridge insertion instructions and associated misuse risks.

    Verbatim wording from the response

    “Chek Insight. The only addition to these materials is the Field Safety Notice which reinforced instructions for insertion of the cartridge - this was supplied to all Accu-Chek Insight pump users who are registered with Roche and to relevant Healthcare Professionals in May 2016.”

    Source location

    2016-0269-Response-by-Roche-Diabetes-Care-Limited
    Page 3 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update pump training sessions using the new Training Handling chart to reinforce correct insulin-cartridge insertion instructions.

    Verbatim wording from the response

    “As part of our Field Safety Notice we initiated updates to the pump training sessions with immediate effect. This focused on the use of the new Training Handling chart (see Annex B) as part of the reinforced instructions for correct insertion of the insulin cartridge.”

    Source location

    2016-0269-Response-by-Roche-Diabetes-Care-Limited
    Page 5 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Incorporate the Field Safety Notice’s reinforced cartridge-insertion instructions into the product manual supplied with new pumps.

    Verbatim wording from the response

    “From October 2016, the reinforced information set out in the FSN will be incorporated in the Accu-Chek Insight insulin pump product manual”

    Source location

    2016-0269-Response-by-Roche-Diabetes-Care-Limited
    Page 4 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review how to support greater uptake and consistency of structured education, including content on incorrect pump use and hyperglycaemia management.

    Verbatim wording from the response

    “NHS England is currently reviewing how greater take-up and consistency of structured education can be supported and the issues of key content in relation to the risks from incorrect use of insulin pumps and the management of hyperglycaemia will be considered as part of this.”

    Source location

    2016-0269-Response-by-NHS-England
    Page 1 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Ensure health boards’ insulin pump services meet NICE safety standards, including annual education updates.

    Verbatim wording from the response

    “The National Diabetes Delivery Plan for Wales recognises the importance of insulin pump provision and structured diabetes education (SDE). With regard to insulin pumps, the plan commits health boards to the provision of an insulin pump service in line with National Institute for Health and Care Excellence (NICE) guidance. As a result, our Diabetes Implementation Group has identified insulin pump provision as one of its national priority areas and has a specific line of activity aimed at health boards ensuring standards of safety comply with NICE guidelines including annual education updates.”

    Source location

    2016-0269-Response-by-Welsh-Government
    Page 2 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Conduct a further risk assessment of the insulin pump safety message.

    Verbatim wording from the response

    “In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.”

    Source location

    2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
    Page 1 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Disseminate reinforced cartridge-changing instructions through a Medical Device Alert, press release and National Medical Device Safety Officers’ Webex.

    Verbatim wording from the response

    “In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.”

    Source location

    2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
    Page 1 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing information and training adequately explain insulin-pump misuse risks, hyperglycaemia management and cartridge insertion consequences.

    Verbatim wording from the response

    “We believe this information is clear and comprehensive, to the extent that general clinical information may properly be supplied to patients by a pump manufacturer.”

    Source location

    2016-0269-Response-by-Roche-Diabetes-Care-Limited
    Page 4 · response
    Published 27 July 2016

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Training healthcare professionals and patients is outside the respondent’s remit; manufacturers and healthcare providers have related instructional and training responsibilities.

    Verbatim wording from the response

    “In order to fulfil the requirements of the Medical Devices Directive and place a medical device on the market, the manufacturer must provide sufficient information and instructions to enable users of the device to operate it in accordance with its intended function. This should include any warnings and precautions to take and any undesirable side effects. The manufacturer should take into consideration the training and capacity of the intended user and, where appropriate, instructions should be provided in symbol form.”

    Source location

    2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
    Page 1 · response
    Published 27 July 2016

    Open published response
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Data last updated 7 September 2026