PFD report

Chimezie DANIELS · Prevention of Future Deaths report

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Issued 16 Jul 2021•Inner North London

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.

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Concerns
2

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
6

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. Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards
    Part of recurring concern: Unreliable alarm controls for oxygen therapyPart of recurring concern: Unreliable patient-monitoring alarm systems
  2. Failure of CPAP alarms to distinguish minor mask leaks from total cessation of oxygen supply
    Part of recurring concern: Unreliable alarm controls for oxygen therapy
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.4

  1. Action

    Search the MHRA adverse-incident and corrective-action database for comparable ventilator alarm events.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 3 August 2021.
  2. Action

    Review the designated medical-equipment alarm standard and its application to alarm severity and prioritisation.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 3 August 2021.
  3. Action

    Engage respiratory and anaesthesia professional bodies to explore training and healthcare-system measures addressing audible alarm prioritisation.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 3 August 2021.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    Existing internationally recognised alarm standards, user training and manufacturer guidance sufficiently mitigate residual risks, so wholesale audible alarm redesign is not justified.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting 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

Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards

Wider context from the report

“At inquest, I heard that on most CPAP machines, the alarm that sounds for a very small leak from the mask is no different from the alarm that sounds for total cessation in oxygen supply. Clinicians told me that it would be much more helpful if very serious matters were denoted by an urgent alarm, and less serious matters in another way. When the alarm on Mr Daniels’ machine sounded, there were four other alarms sounding simultaneously for the four other patients in the bay where he was being nursed. This gave the determination of the cause of his low oxygen saturations an added complexity, particularly at a time in the pandemic when there was so much pressure on beds that CPAP patients were being nursed on medical wards rather than in the high dependency unit. I appreciate that there will not always be an intention to connect to an oxygen supply. Nevertheless, I am sure that further consideration can be given to the issue that the inquest touching Mr Daniels’ death has highlighted. ”

Is this part of a recurring concern?

Yes — Unreliable alarm controls for oxygen therapy; Unreliable patient-monitoring alarm systems.

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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 of CPAP alarms to distinguish minor mask leaks from total cessation of oxygen supply

Wider context from the report

“At inquest, I heard that on most CPAP machines, the alarm that sounds for a very small leak from the mask is no different from the alarm that sounds for total cessation in oxygen supply. Clinicians told me that it would be much more helpful if very serious matters were denoted by an urgent alarm, and less serious matters in another way. When the alarm on Mr Daniels’ machine sounded, there were four other alarms sounding simultaneously for the four other patients in the bay where he was being nursed. This gave the determination of the cause of his low oxygen saturations an added complexity, particularly at a time in the pandemic when there was so much pressure on beds that CPAP patients were being nursed on medical wards rather than in the high dependency unit. I appreciate that there will not always be an intention to connect to an oxygen supply. Nevertheless, I am sure that further consideration can be given to the issue that the inquest touching Mr Daniels’ death has highlighted. ”

Is this part of a recurring concern?

Yes — Unreliable alarm controls for oxygen therapy.

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

Search the MHRA adverse-incident and corrective-action database for comparable ventilator alarm events.

Verbatim wording from the response

“A search of the MHRA database of reported adverse incidents and corrective actions relating to all types of ventilators over the past 5 years has not identified any similar reports where an inability to identify the device fault from the audible alarm tone has been reported.”

Source location

2021-0255-Response-from-MHRA_Published
Page 5 · response
Published 3 August 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

Review the designated medical-equipment alarm standard and its application to alarm severity and prioritisation.

Verbatim wording from the response

“1. We reviewed the designated standard available relating to alarms on medical equipment, ‘EN 60601-1-8:2007+A11:2017 Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems’. This standard provides guidance to medical device manufacturers on requirements for alarm systems, including how the alarms should sound to allow users to prioritise action by level of risk involved. Philips have confirmed that they used the international (ISO) version of this standard during the design of their product. The text is the same in both standards.”

Source location

2021-0255-Response-from-MHRA_Published
Page 5 · response
Published 3 August 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

Engage respiratory and anaesthesia professional bodies to explore training and healthcare-system measures addressing audible alarm prioritisation.

Verbatim wording from the response

“4. We are engaging with the Association of Respiratory Nurse Specialists to explore how the current training programme addresses the issue of audible alarm prioritisation, and whether there may be more actions for the health care system to take to mitigate the risk. We are also engaging with the Royal College of Anaesthetists and Association of Anaesthetists for their input into how this issue can be addressed.”

Source location

2021-0255-Response-from-MHRA_Published
Page 5 · response
Published 3 August 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

Engage with the Faculty for Intensive Care Medicine to include disconnection-alarm guidance addressing alarm indications and response urgency.

Verbatim wording from the response

“• The national patient safety team continues to work with the Faculty for Intensive Care Medicine to develop guidance on the setting up of breathing circuits and we will engage with them to include guidance on disconnection alarms to ensure staff are aware of what each alarm may be indicating and the relative urgency to respond to an alarm.”

Source location

2021-0255-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 3 August 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

Existing internationally recognised alarm standards, user training and manufacturer guidance sufficiently mitigate residual risks, so wholesale audible alarm redesign is not justified.

Verbatim wording from the response

“1. We reviewed the designated standard available relating to alarms on medical equipment, ‘EN 60601-1-8:2007+A11:2017 Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems’. This standard provides guidance to medical device manufacturers on requirements for alarm systems, including how the alarms should sound to allow users to prioritise action by level of risk involved. Philips have confirmed that they used the international (ISO) version of this standard during the design of their product. The text is the same in both standards.”

Source location

2021-0255-Response-from-MHRA_Published
Page 5 · response
Published 3 August 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 available evidence does not indicate a wider safety concern involving inability to identify ventilator faults from audible alarm tones.

Verbatim wording from the response

“Information supplied by Philips Respironics states they are aware of 11 reports worldwide of events involving alarms which were not acknowledged or addressed during the last 3 years. Of these, 8 involved alarms which were not acknowledged by the caregiver, one concerned a device which alarmed but was not acted upon as the family were on another floor, one involved a patient who went into cardiac arrest before the caregiver acknowledged the alarm, and one involved a patient who desaturated before the caregiver acknowledged the alarm. None of these occurred in the UK and none involved failure of the device.”

Source location

2021-0255-Response-from-MHRA_Published
Page 5 · response
Published 3 August 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

Changes to CPAP alarm design fall within the Medicines and Healthcare products Regulatory Agency’s remit.

Verbatim wording from the response

“The main area of concern that you raised within the Preventing Future Deaths report relates to the alarm sound and whether there should be a different sound for ‘serious matters’. This will require a change in the design of the associated medical devices which would fall into the remit of the Medicines and Healthcare products Regulatory Agency (MHRA).”

Source location

2021-0255-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 3 August 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 developing guidance on setting up breathing circuits with the Faculty for Intensive Care Medicine.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 3 August 2021.
  2. 2

    Contribute safety recommendations and an alarm-checking checklist to published guidance for respiratory support units.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 3 August 2021.

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 developing guidance on setting up breathing circuits with the Faculty for Intensive Care Medicine.

Verbatim wording from the response

“• The national patient safety team continues to work with the Faculty for Intensive Care Medicine to develop guidance on the setting up of breathing circuits and we will engage with them to include guidance on disconnection alarms to ensure staff are aware of what each alarm may be indicating and the relative urgency to respond to an alarm.”

Source location

2021-0255-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 3 August 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

Contribute safety recommendations and an alarm-checking checklist to published guidance for respiratory support units.

Verbatim wording from the response

“• The national patient safety team worked closely with the British Thoracic Society during the development of their recently published guidance on Respiratory Support Units to ensure that several key safety issues were addressed in the guidance. This included recommendations that ‘local protocols should be in place to detect disconnection from CPAP and NIV and will include disconnection alarms on machines and defining the protocols for the frequency of nursing review especially for patient nursed in side rooms’ and ‘all machines should, at a minimum, have a disconnection alarm … where patients are nursed in side rooms, the alarm should be audible from outside the room.’ The BTS guidance also includes a checklist which provides an additional safety intervention and includes checking alarms and that the device is actually attached to oxygen.”

Source location

2021-0255-Response-from-NHS-England-and-NHS-Improvement_Published
Page 2 · response
Published 3 August 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