PFD report

James Wilson Fyfe · Prevention of Future Deaths report

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Issued 5 Jan 2015•Berkshire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
2

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
10

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Failure to highlight the cot-side locking problem in all trolley maintenance schedules
    Part of recurring concern: Unreliable safety controls for cots and cot sides
  2. Failure to escalate and notify trolley users of the known cot-side locking risk
    Part of recurring concern: Unreliable multi-agency communication procedures
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.6

  1. Action

    Update the Clinical Engineering Checklist to specify required checks during every QA3 trolley inspection.

    Stated by Royal Berkshire NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 5 January 2015.
  2. Action

    Discuss the QA3 trolley servicing-schedule issue with MHRA to support resolution with AA.

    Stated by Royal Berkshire NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 5 January 2015.
  3. Action

    Require AA to inspect and maintain QA3 trolleys in accordance with the updated Clinical Engineering Checklist as an interim measure.

    Stated by Royal Berkshire NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 5 January 2015.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.6

  1. Position

    The Trust considers its Clinical Engineering Checklist, enforced for interim inspections and maintenance, sufficient to address the maintenance-schedule concern in practice.

    Stated by Royal Berkshire NHS Foundation TrustExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to highlight the cot-side locking problem in all trolley maintenance schedules

Wider context from the report

“(1) It was the Jury’s determination on the evidence that the cot side was able to remain in a raised but unlocked position due in part to both the design and maintenance of the trolley. While evidence was given that the Trust had subsequently introduced improved service sheets and had involved the assistance of Anetic Aid Limited in maintenance, repair and training of use of the trolley, it was unclear as to whether this specific problem had been highlighted as needing careful attention in all maintenance schedules for the trolley. ”

Is this part of a recurring concern?

Yes — Unreliable safety controls for cots and cot sides.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to escalate and notify trolley users of the known cot-side locking risk

Wider context from the report

“(2) The Jury were informed that MHRA were aware of the investigations of the incident trolley but that it did not appear that the issue had been escalated and notified to all Hospital Trusts and agencies that used this type of trolley. The MHRA’s actions in being informed of this potential hazard remain unclear, with particular reference to passing on the known risk to such trolley users. ”

Is this part of a recurring concern?

Yes — Unreliable multi-agency communication procedures.

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

Update the Clinical Engineering Checklist to specify required checks during every QA3 trolley inspection.

Verbatim wording from the response

“2. The Trust has further updated its Clinical Engineering Checklist for AA QA3 trolleys to expressly detail the checks that must be undertaken during every inspection of a QA3 trolley.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 1 · response
Published 5 January 2015

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

Discuss the QA3 trolley servicing-schedule issue with MHRA to support resolution with AA.

Verbatim wording from the response

“At the conclusion of the Inquest into JF’s death, the Trust entered into discussions with the Medicines and Healthcare Products Regulatory Agency (“MHRA”), which sets the standards for the management of medical devices, including trolleys. The MHRA is in discussions with AA to resolve the servicing schedule issue.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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 AA to inspect and maintain QA3 trolleys in accordance with the updated Clinical Engineering Checklist as an interim measure.

Verbatim wording from the response

“However, as an interim measure, the Trust insists that AA inspects and maintains its QA3 trolleys in accordance with its Clinical Engineering Checklist, which the Trust believes, in practice, deals with your fourth concern under the R.28 Report.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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 and re-instate a Trust-wide trolley safety campaign through computer screensavers, posters and updated training-website instructions.

Verbatim wording from the response

“3. After the incident the Trust instigated a “Remember ‘Clunk – Click’ every trip” campaign across the Trust. The campaign included placing a ‘Clunk – Click’ screen saver on Trust computers, placing campaign posters strategically across the Trust and ensuring updated user instructions were added to the Trust’s training website. This campaign was re-instigated across the Trust in January 2015.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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

Correspond with AA to seek amendment of the QA3 trolley servicing schedule.

Verbatim wording from the response

“4. Responsibility for developing QA3 trolley maintenance schedules lies with AA as the trolley manufacturer and following the Inquest into JF’s death, the Trust entered into correspondence with AA with a view to AA amending its servicing schedule for QA3 trolleys.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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

Contract AA to conduct periodic inspections and required maintenance of QA3 trolleys, documenting faults and remedial actions.

Verbatim wording from the response

“1. The Trust has contracted with AA to undertake periodic inspection and as required maintenance on all of its QA3 trolleys. AA engineers provide the Trust with a ‘maintenance entry sheet’ during every inspection/maintenance visit to the Trust detailing the trolleys inspected, the faults identified and the actions taken to remedy those faults.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 1 · response
Published 5 January 2015

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 Trust considers its Clinical Engineering Checklist, enforced for interim inspections and maintenance, sufficient to address the maintenance-schedule concern in practice.

Verbatim wording from the response

“However, as an interim measure, the Trust insists that AA inspects and maintains its QA3 trolleys in accordance with its Clinical Engineering Checklist, which the Trust believes, in practice, deals with your fourth concern under the R.28 Report.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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

Responsibility for developing QA3 trolley maintenance schedules lies with the manufacturer, Anetic Aid Limited.

Verbatim wording from the response

“4. Responsibility for developing QA3 trolley maintenance schedules lies with AA as the trolley manufacturer and following the Inquest into JF’s death, the Trust entered into correspondence with AA with a view to AA amending its servicing schedule for QA3 trolleys.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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 Trust has no control over securing a permanent solution to the QA3 trolley servicing-schedule concern.

Verbatim wording from the response

“In summary, the Trust believes that it has taken all appropriate steps to address all of your concerns under R28. While no permanent solution has been found to that fourth concern expressed under Regulation 28, this matter is outside the Trust’s control.”

Source location

2015-0099-Response-by-Royal-Berkshire-NHS-Trust
Page 2 · response
Published 5 January 2015

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

MHRA considered a Medical Device Alert unnecessary because evidence and risk assessment did not justify additional safety messaging.

Verbatim wording from the response

“MHRA did not publish a Medical Device Alert (MDA) concerning the QA3 Patient Trolley. At the time of the incident 11,090 QA3 trolleys had been produced with the same design of locking mechanism for the side rails. There were no prior related incidents reported to either MHRA or Anetic Aid Ltd for the period the trolley had been placed on the market, 1998 to 2011. It is important to note that not all incidents result in the issue of a MDA. MHRA received 10,984 incident reports (relating to 21,729 incidents) in 2011 and issued 114 MDAs. There would be a real risk of diluting the impact and importance of alerts if the system were to be used to distribute large numbers of alerts. In addition, Government agencies are trying to reduce the burden on the NHS and are working with fewer resources themselves.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 5 January 2015

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

Available reports indicated the QA3 side-rail problem was local to RBH rather than a wider problem across hospitals.

Verbatim wording from the response

“MHRA review of incident - 2015 The current version of the QA3 trolley uses the same type of locking mechanism and it is essentially unchanged, having the same characteristics. Anetic Aid Ltd state that QA3 sales now total 11,680 units. Since the incident in 2011 there have been no further reports to MHRA or to the manufacturer of any users other than RBH experiencing problems with the side rails not locking when they are raised. RBH sent us reports in March 2013 and November 2014 which were added to the surveillance database, each detailing one failure.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 5 January 2015

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

Retrospective changes to QA3 side-rail design, performance or maintenance are not considered necessary because this is the only reported incident and concern is localised.

Verbatim wording from the response

“The incident involved in Mr Fyfe’s death remains the only reported incident of this nature and Royal Berkshire Hospital is the only known site where an issue with the side rail performance has been raised as a concern.”

Source location

2015-0099-Response-by-AneticAid
Page 2 · response
Published 5 January 2015

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. 1

    Transfer the incident to the MHRA surveillance database.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2015.
  2. 2

    Review the manufacturer’s investigation of the incident and assess its apparent cause.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 January 2015.
  3. 3

    Remind Anetic Aid to follow its quality system and ensure all customers are offered trolley-use training.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 5 January 2015.
  4. 4

    Deliver and continue supporting QA3 end-user training for Royal Berkshire Hospital staff.

    Stated by AneticAidStated in progressThe respondent said that this action was in progress when they made their response on 5 January 2015.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.3

  1. 1

    Existing instructions were considered sufficient for safe side-rail use when combined with appropriate user training.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
  2. 2

    MHRA would not normally require device or instruction changes without further reports or evidence showing the device was not functioning as intended.

    Stated by Medicines and Healthcare products Regulatory AgencyUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
  3. 3

    The QA3 side-rail design is not shown to require additional safety features, which could reduce usability and create other unacceptable risks.

    Stated by AneticAidDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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

Transfer the incident to the MHRA surveillance database.

Verbatim wording from the response

“MHRA review of incident - 2011 Anetic Aid sent MHRA their investigation report on 6 April 2011. ████████ reviewed their investigation report and based on this report, agreed the cause of the incident appeared to be user error and not equipment failure. The incident was transferred to our surveillance database in September 2011.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 5 January 2015

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 the manufacturer’s investigation of the incident and assess its apparent cause.

Verbatim wording from the response

“MHRA review of incident - 2011 Anetic Aid sent MHRA their investigation report on 6 April 2011. ████████ reviewed their investigation report and based on this report, agreed the cause of the incident appeared to be user error and not equipment failure. The incident was transferred to our surveillance database in September 2011.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 5 January 2015

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

Remind Anetic Aid to follow its quality system and ensure all customers are offered trolley-use training.

Verbatim wording from the response

“MHRA will remind Anetic Aid Ltd to follow their Quality System and ensure all customers are offered training in the use of these trolleys.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 3 · response
Published 5 January 2015

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 and continue supporting QA3 end-user training for Royal Berkshire Hospital staff.

Verbatim wording from the response

“As has been recognised, we have commenced with a programme of QA3 end user training with Royal Berkshire Hospital staff, and this has been on-going since the incident. We will actively continue to support this. Through our communication with the Hospital, we understand a program of safety notices and reminders to staff, highlighting the careful use of side rail, has been undertaken. We would suggest this to be an effective way of addressing what we perceive to be a localised issue.”

Source location

2015-0099-Response-by-AneticAid
Page 2 · response
Published 5 January 2015

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 instructions were considered sufficient for safe side-rail use when combined with appropriate user training.

Verbatim wording from the response

“Mr Marsden visited RBH on 14 January 2015 to examine some examples of their QA3 trolleys that they felt had safety issues with the side rails. Whilst there was evidence of some components being defective, such as damping springs, and a variance in the force needed to raise the side rails was apparent, the locking mechanisms seen on all examples were fully functional and, following the instructions for use, were intuitive to use.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 5 January 2015

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

MHRA would not normally require device or instruction changes without further reports or evidence showing the device was not functioning as intended.

Verbatim wording from the response

“Summary MHRA does not normally require manufacturers to modify medical devices or instructions for use on the basis of a single report or a single report source, unless it is clear from the report that the device did not function as intended. Enough evidence needs to be gathered in the form of further reports or other evidence before it can be argued that the device is not functioning as intended. It is important for reporters to continue to report further adverse incidents when they happen, rather than assuming that nothing will come of these reports. When enough evidence is submitted, MHRA will act within the measures of the law. It is through these systems, coupled with joint partnership working with the NHS that MHRA can help to protect the safety of medical devices users.”

Source location

2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 3 · response
Published 5 January 2015

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 QA3 side-rail design is not shown to require additional safety features, which could reduce usability and create other unacceptable risks.

Verbatim wording from the response

“Naturally following the incident at Royal Berkshire Hospital, we have been rigorously examining our design criteria and our user safety records. Based on extensive post market surveillance, we find the design has a 100% safety record in its primary role of retaining the side rail in a raised position when locked – irrespective of levels of maintenance, or variations in performance.”

Source location

2015-0099-Response-by-AneticAid
Page 1 · response
Published 5 January 2015

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026