PFD report

Mary Land · Prevention of Future Deaths report

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Issued 29 Sep 2021•West Yorkshire Eastern

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
1

Raised in this report

Recipients
3

Named on the report

Responses found
4

Of 3 recipients

Stated actions
8

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 raised1

  1. Use of a mask-to-tubing push-on connection vulnerable to coming apart
    Part of recurring concern: Unsafe ventilator operation and safety controls
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

    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.
  2. 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.
  3. 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.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.5

  1. 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.

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

Use of a mask-to-tubing push-on connection vulnerable to coming apart

Wider context from the report

“The Philips Respironics AF 541 mask connects to the tubing, linking it to the BIPAP ventilator by means of a ‘push on’ connection (rather than a fitting involving positive engagement). Evidence taken at the Inquest indicates this connection has come undone on other occasions as well. The introduction of a filter at the site of this union increases the potential for the joint to come apart. Consideration should be given to installing a more robust docking mechanism which is less vulnerable to working loose, or being inadvertently pulled apart, for example, by a patient suffering from delirium. ”

Is this part of a recurring concern?

Yes — Unsafe ventilator operation and safety controls.

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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

Engage Philips Respironics on maintaining compliance with the latest relevant designated or harmonised standards.

Verbatim wording from the response

“- Engage with Philips Respironics regarding maintaining compliance to the latest version of relevant and Designated or Harmonised Standards - Contact the British Thoracic Society and NICE to agree a time to discuss updating the published guidance relating to the management of COVID-19 patients to ensure that health care professionals prescribing and setting up breathing circuits and the inclusion of filters are in accordance with the breathing system device manufacturers’ instructions.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 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

Review current connector standards for breathing circuits.

Verbatim wording from the response

“We have reviewed the current versions of ISO standards for connectors used within breathing circuits: BS EN ISO 5356-1:2015 and BS EN ISO 5356-2:2012.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 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

Agree Philips Respironics’ investigation plan and update schedule, ensuring assessment of connection design, filter use, disconnection risk, patient harm and corrective actions.

Verbatim wording from the response

“By the end of November 2021: - Agree with Philips Respironics their investigation plan and a regular schedule for updates to be provided to MHRA, ensuring it is concluded in line with their regulatory obligations and any corrective actions identified are conducted. This includes ensuring they assess the impact of the connection design and the inclusion of the filter within the breathing circuit on the disconnection event and patient harm and measures to minimise this risk in the future.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 2021

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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 with the British Thoracic Society and NICE updating guidance on breathing-circuit setup and filter use in accordance with manufacturers’ instructions.

Verbatim wording from the response

“- Engage with Philips Respironics regarding maintaining compliance to the latest version of relevant and Designated or Harmonised Standards - Contact the British Thoracic Society and NICE to agree a time to discuss updating the published guidance relating to the management of COVID-19 patients to ensure that health care professionals prescribing and setting up breathing circuits and the inclusion of filters are in accordance with the breathing system device manufacturers’ instructions.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 2021

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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

Investigate manufacturer or other solutions and discuss with regional units how to improve tubing-circuit connection stability.

Verbatim wording from the response

“Recommendation 2: Scope and discuss with regional units if there can be an improvement on securing tubing circuit connections”

Source location

2021-0322-Response-from-Mid-Yorkshire-Hospitals_Published-1
Page 2 · response
Published 5 October 2021

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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 filter use and its effect on circuit stability with the Respiratory Team and non-invasive ventilation lead.

Verbatim wording from the response

“Unfortunately, the additional filter component inserted between the facemask and the ventilator tubing may have contributed to destabilisation of the circuit, although this cannot be clinically proven, and there is no current research/evidence to confirm or reject the theory that the additional filter caused/causes destabilisation of the circuit.”

Source location

2021-0322-Response-from-Mid-Yorkshire-Hospitals_Published-1
Page 2 · response
Published 5 October 2021

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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

Screw-thread connectors could make urgent component changes difficult and introduce risk; push-fit disconnection risk is no greater than patient mask removal.

Verbatim wording from the response

“In October 2021 we conducted stakeholder engagement with the Association of Respiratory Nurses in order to seek qualitative feedback on the use of breathing masks, tubing and filters and the means of connecting them to make a complete breathing circuit. In summary they stated that, connections between masks and hoses are universal and push-fit allowing for compatibility between the various manufacturer’s equipment. If the connection became a screw-thread style, then the ability to change and consumeable components, when required and when in situ, would be more difficult. It could cause components to seize up, making quick changes difficult. This could put in place a further risk, when a patient is dependent on therapy, and a quick mask/hose change is needed. They also acknowledged that the risk of disconnection is no more than patients removing masks themselves.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 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

When design solutions were researched, no all-in-one circuit integrating the filter into the mask was available.

Verbatim wording from the response

“Of note, at the time when the incident was investigated and design solutions were researched, there was no all-in-one circuit available, i.e. where the filter was an integral constituent of the mask, rather than an optional add-on component. As such, the Trust thanks you for raising this issue directly with the manufacturer, Philips Respironics.”

Source location

2021-0322-Response-from-Mid-Yorkshire-Hospitals_Published-1
Page 2 · response
Published 5 October 2021

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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

No design action is proposed for the AF541’s non-latching connection because it meets the applicable mask-to-circuit connection standard.

Verbatim wording from the response

“The last two circuit disconnect alarms logged were not acknowledged for a total of more than 27 minutes. Shortly after 5:00:00, the ventilator was turned off. Based on the information reviewed by the manufacturer – specifically the greater than 30 minutes of active alarming of the device, hospital verification that the circuit disconnect alarm sounded, incorrect connection of an inline filter, and use of an unapproved inline filter, Philips Respironics concludes that the AF541 mask and Trilogy EVO ventilator operated as designed. The facility apparently failed to follow the manufacturer’s instructions and did not respond appropriately to ventilator alarms. In addition, the mask at issue meets the applicable standard for mask to circuit connection. Therefore, no action for the design of the AF541 22mm non-latching conical connection is proposed.”

Source location

2021-0322-Response-from-Philips_Published-1
Page 2 · response
Published 5 October 2021

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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 ventilator and mask operated as designed, while the facility used an unapproved configuration and failed to respond appropriately to alarms.

Verbatim wording from the response

“The last two circuit disconnect alarms logged were not acknowledged for a total of more than 27 minutes. Shortly after 5:00:00, the ventilator was turned off. Based on the information reviewed by the manufacturer – specifically the greater than 30 minutes of active alarming of the device, hospital verification that the circuit disconnect alarm sounded, incorrect connection of an inline filter, and use of an unapproved inline filter, Philips Respironics concludes that the AF541 mask and Trilogy EVO ventilator operated as designed. The facility apparently failed to follow the manufacturer’s instructions and did not respond appropriately to ventilator alarms. In addition, the mask at issue meets the applicable standard for mask to circuit connection. Therefore, no action for the design of the AF541 22mm non-latching conical connection is proposed.”

Source location

2021-0322-Response-from-Philips_Published-1
Page 2 · response
Published 5 October 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 MHRA is responsible for ensuring the device investigation complies with regulations and that any identified corrective action is taken.

Verbatim wording from the response

“I have been made aware that the Medicine and Healthcare products Regulatory Agency (MHRA), the regulator of medical devices and medicinal products, has provided a response to your report explaining the actions it has taken in relation to this incident and the concerns raised. You will therefore be aware that following the outcome of the inquest into Mrs Land’s death, Phillips Respironics has extended its investigation to look at the connection tubing and facemask. Phillips has also been asked by the MHRA to investigate the potential impact on performance of the breathing circuit of using a filter in the facemask. A final report of the investigation has been requested by the MHRA, and the MHRA will ensure that the investigation has been conducted in line with the relevant regulations and that any corrective action identified is taken.”

Source location

2021-0322-Response-from-Department-of-Health-and-Social-Care_Published-1
Page 1 · response
Published 5 October 2021

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.2

  1. 1

    Continue assessing incoming data for safety signals involving these devices and take action when required.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 5 October 2021.
  2. 2

    Conduct stakeholder engagement on breathing-circuit connections, masks, tubing and filters.

    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.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.2

  1. 1

    The filter remains necessary and is being used in accordance with current BTS guidance for COVID-19 infection prevention.

    Stated by Mid Yorkshire Teaching NHS TrustExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
  2. 2

    The CQC considers the Trust’s action plan satisfactory and will continue monitoring under its current regulatory approach.

    Stated by Department of Health and Social CareExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Continue assessing incoming data for safety signals involving these devices and take action when required.

Verbatim wording from the response

“Ongoing: - Continue to assess incoming data which identifies a new safety signal with these types of devices and take action when required.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 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 stakeholder engagement on breathing-circuit connections, masks, tubing and filters.

Verbatim wording from the response

“In October 2021 we conducted stakeholder engagement with the Association of Respiratory Nurses in order to seek qualitative feedback on the use of breathing masks, tubing and filters and the means of connecting them to make a complete breathing circuit. In summary they stated that, connections between masks and hoses are universal and push-fit allowing for compatibility between the various manufacturer’s equipment. If the connection became a screw-thread style, then the ability to change and consumeable components, when required and when in situ, would be more difficult. It could cause components to seize up, making quick changes difficult. This could put in place a further risk, when a patient is dependent on therapy, and a quick mask/hose change is needed. They also acknowledged that the risk of disconnection is no more than patients removing masks themselves.”

Source location

2021-0322-Response-from-MHRA_Published-1
Page 3 · response
Published 5 October 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 filter remains necessary and is being used in accordance with current BTS guidance for COVID-19 infection prevention.

Verbatim wording from the response

“The inclusion of a filter to manage COVID-19 patients was recommended as part of the British Thoracic Society (BTS) Guidance issued in Wave 1 of the Pandemic (refer Attachment 2). At date, this advice remains current and is considered best practice for infection prevention and control purposes of COVID-19 patients on non-invasive ventilation.”

Source location

2021-0322-Response-from-Mid-Yorkshire-Hospitals_Published-1
Page 2 · response
Published 5 October 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 CQC considers the Trust’s action plan satisfactory and will continue monitoring under its current regulatory approach.

Verbatim wording from the response

“I am advised that the Mid Yorkshire Hospitals NHS Trust has taken learning from its own investigation of the circumstances around Mrs Land’s death. This includes actions relating to the response to the device alarm. I am further advised that the Care Quality Commission (CQC) is satisfied with the Trust’s action plan and will continue to monitor the Trust in line with its current regulatory approach.”

Source location

2021-0322-Response-from-Department-of-Health-and-Social-Care_Published-1
Page 1 · response
Published 5 October 2021

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