First reported 17 Mar 2016•Latest report 17 Jan 2023
Definition
What this concern includes
Includes failures of controls specifically dedicated to safe ventilator operation, including staff training and access to operating guidance, fault recognition, display or configuration standardisation, equipment safety assessment and removal from service when indicated.
Not included
Excludes generic clinical-equipment availability, maintenance or serviceability deficiencies unless they specifically concern ventilator operation or ventilator-related fault control.
Excludes generic staff training, documentation or information-access failures not directly tied to safe ventilator operation.
Excludes failures in patient monitoring, respiratory treatment or clinical decision-making where ventilator safety is not the identified unsafe condition.
Excludes unrelated equipment, such as vehicle lifts, piling rigs or transformers, even where manuals or warnings are deficient.
Reports
5
Distinct published reports
Individual concerns
8
A report can raise multiple concerns
Date range
2016–2023
First to latest report issue date
Stated actions
20
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
Avon Care Homes Limited1
Care Quality Commission1
Mid Yorkshire Teaching NHS Trust1
Milton Keynes University Hospital1
NHS England1
Philips Electronics UK Limited1
Philips Respironics1
Royal College of Anaesthetists1
St George'S University Hospitals NHS Foundation Trust1
St Richard's Hospital1
University Hospitals Sussex NHS Foundation Trust1
Ministerial department3
NHS trust3
Healthcare site2
Private limited company2
Executive non-departmental public body1
Health and social care service regulator1
Health professional body1
Multi-service care provider1
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.
West Sussex
Concerns raised1
Failure to remove and assess anaesthetic equipment for faults after a suspected equipment-related event
This report raised 8 other concerns. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.8
Action
Seek confirmation that the Trust has an established process to isolate medical equipment potentially involved in an event.
Stated by Care Quality CommissionStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Amend guidance to require a standardised investigation process automatically triggered immediately after a catastrophic event.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Promote the amended catastrophic-event investigation process to the anaesthesia specialty.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Embed the amended catastrophic-event investigation process through the Royal College of Anaesthetists’ Anaesthesia Clinical Services Accreditation scheme.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Review guidance to identify the need for a standardised investigation process automatically triggered after catastrophic events.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated completedThe respondent said that this action was complete when they made their response on 23 January 2023.
Action
Amend guidance to specify a standardised investigation process automatically triggered immediately after catastrophic events.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Promote the amended catastrophic-event investigation process to the anaesthesia specialty.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Action
Embed the amended catastrophic-event investigation process through the Royal College of Anaesthetists’ Anaesthesia Clinical Services Accreditation scheme.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 23 January 2023.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
Position
RCoA is responsible for clarifying anaesthetic-machine arrangements in its guidance, while CQC will respond to the report and recommendations.
Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
The identified care, evidence-handling, Duty of Candour and investigation concerns fall outside HEE’s current role and statutory responsibilities.
Stated by NHS EnglandOutside remitThe respondent said that this matter was outside its role or authority.
West Yorkshire Eastern
Concerns raised1
Use of a mask-to-tubing push-on connection vulnerable to coming apart
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 respondent says it has done, is doing, or plans to do in response to the concern raised.6
Action
Review current connector standards for breathing circuits.
Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 October 2021.
Action
Agree Philips Respironics’ investigation plan and update schedule, ensuring assessment of connection design, filter use, disconnection risk, patient harm and corrective actions.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 5 October 2021.
Action
Engage Philips Respironics on maintaining compliance with the latest relevant designated or harmonised standards.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 5 October 2021.
Action
Discuss with the British Thoracic Society and NICE updating guidance on breathing-circuit setup and filter use in accordance with manufacturers’ instructions.
Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 5 October 2021.
Action
Investigate manufacturer or other solutions and discuss with regional units how to improve tubing-circuit connection stability.
Stated by Mid Yorkshire Teaching NHS TrustStated completedThe respondent said that this action was complete when they made their response on 5 October 2021.
Action
Discuss filter use and its effect on circuit stability with the Respiratory Team and non-invasive ventilation lead.
Stated by Mid Yorkshire Teaching NHS TrustStated completedThe respondent said that this action was complete when they made their response on 5 October 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.5
Position
Screw-thread connectors could make urgent component changes difficult and introduce risk; push-fit disconnection risk is no greater than patient mask removal.
Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Position
When design solutions were researched, no all-in-one circuit integrating the filter into the mask was available.
Stated by Mid Yorkshire Teaching NHS TrustUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Position
The ventilator and mask operated as designed, while the facility used an unapproved configuration and failed to respond appropriately to alarms.
Stated by Philips Respironics - Sleep and Respiratory CareDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Position
No design action is proposed for the AF541’s non-latching connection because it meets the applicable mask-to-circuit connection standard.
Stated by Philips Respironics - Sleep and Respiratory CareNo action considered necessaryThe respondent said that no further action was needed.
Position
The MHRA is responsible for ensuring the device investigation complies with regulations and that any identified corrective action is taken.
Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Milton Keynes
Concerns raised1
Inconsistent ventilator display configurations across clinical areas
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.2
Action
Work with anaesthetic and respiratory device suppliers to support development of engineered solutions for variable monitor displays and alarm configurations.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Difficult Airway Society and Royal College of AnaesthetistsStated plannedThe respondent said that this action was planned when they made their response on 9 September 2021.
Action
Work with anaesthetic and respiratory device suppliers to support engineered solutions for variable monitor display and alarm configurations.
Stated by Association Of Anaesthetists (Great Britain & Ireland) and Difficult Airway Society and Royal College of AnaesthetistsStated in progressThe respondent said that this action was in progress when they made their response on 9 September 2021.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
Position
Standardising multiparameter monitor displays could remove necessary flexibility, create unnecessary monitoring requirements and adversely affect patient safety.
Stated by Department of Health and Social CareDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
Wiltshire and Swindon
Concerns raised2
Failure of the ventilator Users Manual extracts to provide guidance on normal operation, fault recognition and fault rectification
Failure to ensure staff awareness of the ventilator Users Manual and its location
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.1
Action
Create an accessible specialist-equipment governance pack covering manuals, settings, checks, risk assessments, policies and best-practice evidence.
Stated by Avon Care Homes LimitedStated plannedThe respondent said that this action was planned when they made their response on 2 November 2016.
Inner West London
Concerns raised3
Failure of the BIPAP display to keep the battery-power indicator visible during multiple alarms
Failure to train BIPAP staff to recognise battery-power indicators and battery-depletion alarms
Failure of the BIPAP alarm system to provide a distinct urgent warning for battery depletion
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
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 respondent says it has done, is doing, or plans to do in response to the concern raised.3
Action
Retrain NIV staff on battery depletion indicators, alarms and Trilogy ventilator safety, with competencies documented for all staff except two new starters.
Stated by St George'S University Hospitals NHS Foundation TrustStatus at responseThe respondent said that this action was partly complete when they made their response on 17 March 2016.
Action
Incorporate battery depletion and alarm-safety content into training delivered by the practice educator and respiratory specialist nurses.
Stated by St George'S University Hospitals NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 17 March 2016.
Action
Consider the adequacy of HTM guidance on alerts relating to power-supply interruptions.
Stated by Department of Health and Social CareStated plannedThe respondent said that this action was planned when they made their response on 17 March 2016.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3
Position
Many concerns require action by Philips Healthcare and the NHS Foundation Trust rather than the Department.
Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
Manufacturers cannot be compelled to improve compliant devices without changes to UK and EU regulatory requirements.
Stated by Department of Health and Social CareUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
Position
Staff involved in the incident were appropriately trained on non-invasive ventilation and the Trilogy ventilator, contrary to the concern raised.
Stated by St George'S University Hospitals NHS Foundation TrustDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
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Includes failures of controls specifically dedicated to safe ventilator operation, including staff training and access to operating guidance, fault recognition, display or configuration standardisation, equipment safety assessment and removal from service when indicated.
