PFD report

MELANIE JAYNE WALKER · Prevention of Future Deaths report

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Issued 17 Oct 2025•Manchester West

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
3

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
3

Described in responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

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

Report evidence summary

Concerns raised3

  1. Failure to ensure staff awareness and training about current heart-monitor deficiencies
  2. Failure of heart monitors to alert clinicians to cardiac events
    Part of recurring concern: Unreliable patient-monitoring alarm systems
  3. Failure of heart monitors to re-alert when ECG leads remain disconnected
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.2

  1. Action

    Reset the IntelliVue “ECG Leads Off” technical alarm to its factory-default medium-priority configuration.

    Stated by PhilipsStated completedThe respondent said that this action was complete when they made their response on 5 November 2025.
  2. Action

    Provide ongoing alarm-management support through staff education, workflow review, data analysis, improvement recommendations, and assistance implementing proposed changes.

    Stated by PhilipsStated in progressThe respondent said that this action was in progress when they made their response on 5 November 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    MHRA is responsible for assessing whether further field safety corrective action or device safety information is necessary.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

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 ensure staff awareness and training about current heart-monitor deficiencies

Wider context from the report

“1. Whilst the deceased had been fitted with a heart monitor whilst being assessed in the busy Resuscitation Department of the hospital, she experienced a cardiac event that ought to have triggered her hearty monitor to alert clinicians to this medical emergency, in fact, this did not occur. 2. A Patient Safety Incident Investigation (PSII) had been commissioned by the Hospital Trust determined: a. Where, an untoward event – such as an abnormal reading, or (as in this case) with a monitor lead was inadvertently disconnected, this creates a blue ‘in op’ alert with a ‘bloop’ type sound (as opposed to a continuous alarm) – with the consequence that the ECG lead is unable to detect a reading and is therefore inoperable. b. The ‘in op’ alert creates a blue banner to alert staff. Once acknowledged (by the staff member pressing the button) this does not re-alert, even if the lead remains disconnected, c. Accordingly, there is a risk that a lead could remain disconnected, if the reason for the staff pressing ‘acknowledge’ is to acknowledge an abnormal reading. d. Whilst Royal Bolton Hospital Trust have mitigated the identified patient safety issues and it understood that the manufacturers (Philips) are undertaking to reconfigure their monitors so that when an ECG lead is removed this creates a ‘yellow alert’ that will ensure that the monitor will re-alarm in the scenario of a patient removing the lead when unobserved – the evidence established that this risk remains an issue for other hospital trusts in the interim. e. Royal Bolton Hospital have identified the need for patients who are deliberately or inadvertently removing monitoring equipment will be the subject of additional support, such as a 1:1 Health Care Assistant. 3. There remains an ongoing concern that until these heart monitoring machines are re-configured, and staff made aware and trained as to their current deficiencies, with no mitigating arrangements in place, that a patient can suffer a fatal cardiac event in any clinical setting and an erroneous assumption made by health care staff that a patient is being appropriately monitored. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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 of heart monitors to alert clinicians to cardiac events

Wider context from the report

“1. Whilst the deceased had been fitted with a heart monitor whilst being assessed in the busy Resuscitation Department of the hospital, she experienced a cardiac event that ought to have triggered her hearty monitor to alert clinicians to this medical emergency, in fact, this did not occur. 2. A Patient Safety Incident Investigation (PSII) had been commissioned by the Hospital Trust determined: a. Where, an untoward event – such as an abnormal reading, or (as in this case) with a monitor lead was inadvertently disconnected, this creates a blue ‘in op’ alert with a ‘bloop’ type sound (as opposed to a continuous alarm) – with the consequence that the ECG lead is unable to detect a reading and is therefore inoperable. b. The ‘in op’ alert creates a blue banner to alert staff. Once acknowledged (by the staff member pressing the button) this does not re-alert, even if the lead remains disconnected, c. Accordingly, there is a risk that a lead could remain disconnected, if the reason for the staff pressing ‘acknowledge’ is to acknowledge an abnormal reading. d. Whilst Royal Bolton Hospital Trust have mitigated the identified patient safety issues and it understood that the manufacturers (Philips) are undertaking to reconfigure their monitors so that when an ECG lead is removed this creates a ‘yellow alert’ that will ensure that the monitor will re-alarm in the scenario of a patient removing the lead when unobserved – the evidence established that this risk remains an issue for other hospital trusts in the interim. e. Royal Bolton Hospital have identified the need for patients who are deliberately or inadvertently removing monitoring equipment will be the subject of additional support, such as a 1:1 Health Care Assistant. 3. There remains an ongoing concern that until these heart monitoring machines are re-configured, and staff made aware and trained as to their current deficiencies, with no mitigating arrangements in place, that a patient can suffer a fatal cardiac event in any clinical setting and an erroneous assumption made by health care staff that a patient is being appropriately monitored. ”

Is this part of a recurring concern?

Yes — Unreliable patient-monitoring alarm systems.

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 of heart monitors to re-alert when ECG leads remain disconnected

Wider context from the report

“1. Whilst the deceased had been fitted with a heart monitor whilst being assessed in the busy Resuscitation Department of the hospital, she experienced a cardiac event that ought to have triggered her hearty monitor to alert clinicians to this medical emergency, in fact, this did not occur. 2. A Patient Safety Incident Investigation (PSII) had been commissioned by the Hospital Trust determined: a. Where, an untoward event – such as an abnormal reading, or (as in this case) with a monitor lead was inadvertently disconnected, this creates a blue ‘in op’ alert with a ‘bloop’ type sound (as opposed to a continuous alarm) – with the consequence that the ECG lead is unable to detect a reading and is therefore inoperable. b. The ‘in op’ alert creates a blue banner to alert staff. Once acknowledged (by the staff member pressing the button) this does not re-alert, even if the lead remains disconnected, c. Accordingly, there is a risk that a lead could remain disconnected, if the reason for the staff pressing ‘acknowledge’ is to acknowledge an abnormal reading. d. Whilst Royal Bolton Hospital Trust have mitigated the identified patient safety issues and it understood that the manufacturers (Philips) are undertaking to reconfigure their monitors so that when an ECG lead is removed this creates a ‘yellow alert’ that will ensure that the monitor will re-alarm in the scenario of a patient removing the lead when unobserved – the evidence established that this risk remains an issue for other hospital trusts in the interim. e. Royal Bolton Hospital have identified the need for patients who are deliberately or inadvertently removing monitoring equipment will be the subject of additional support, such as a 1:1 Health Care Assistant. 3. There remains an ongoing concern that until these heart monitoring machines are re-configured, and staff made aware and trained as to their current deficiencies, with no mitigating arrangements in place, that a patient can suffer a fatal cardiac event in any clinical setting and an erroneous assumption made by health care staff that a patient is being appropriately monitored. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Reset the IntelliVue “ECG Leads Off” technical alarm to its factory-default medium-priority configuration.

Verbatim wording from the response

“made at the customer site after installation, nor do we maintain records of such changes or the authorization process for them. In this instance, it is unclear when the adjustment from medium to low priority was made or who authorized the change. It is the responsibility of the clinical site to ensure that any changes to alarm configurations are made in accordance with their internal governance and patient safety policies. Additionally, clinical staff are expected to acknowledge and respond to alarms in line with their training and local procedures, and to ensure that patients remain appropriately monitored. As mentioned in the Regulation 28 Report, Philips has reset the "ECG Leads Off" technical alarm to the factory default configuration [medium priority (yellow)], which better suits the needs of this hospital.”

Source location

Response from Philips
Page 3 · response
Published 5 November 2025

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

Provide ongoing alarm-management support through staff education, workflow review, data analysis, improvement recommendations, and assistance implementing proposed changes.

Verbatim wording from the response

“Given that the equipment was supplied with appropriate factory default settings, and that subsequent changes were made at the customer level, Philips does not propose further action to the default configuration of the devices at this time. However, Philips is and remains dedicated to supporting customers in areas such as alarm management, offering education and guidance to hospital staff on configuring alarms to help reduce alarm fatigue while ensuring the patient receives the best care. Our clinical consultants collaborate directly with clinicians to optimize patient monitoring features, including alarm customization tools. This support also involves a thorough review of current practices and workflows, data analysis, recommendations for improvement, and assistance with implementing proposed changes.”

Source location

Response from Philips
Page 3 · response
Published 5 November 2025

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 is responsible for assessing whether further field safety corrective action or device safety information is necessary.

Verbatim wording from the response

“As next steps, MHRA is currently assessing this notice in line with its internal process flow, which includes an Extensive Review of the controls recommended by Philips and a Risk Assessment of the need for any further Field Safety Corrective Action and/or a Device Safety Information Alert. Should further action be found necessary to prevent future harms, I will ensure you are notified.”

Source location

Response from Department for Health and Social Care
Page 2 · response
Published 5 November 2025

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

No further change to device default alarm configuration is proposed because factory settings were appropriate and later changes occurred at customer level.

Verbatim wording from the response

“Given that the equipment was supplied with appropriate factory default settings, and that subsequent changes were made at the customer level, Philips does not propose further action to the default configuration of the devices at this time. However, Philips is and remains dedicated to supporting customers in areas such as alarm management, offering education and guidance to hospital staff on configuring alarms to help reduce alarm fatigue while ensuring the patient receives the best care. Our clinical consultants collaborate directly with clinicians to optimize patient monitoring features, including alarm customization tools. This support also involves a thorough review of current practices and workflows, data analysis, recommendations for improvement, and assistance with implementing proposed changes.”

Source location

Response from Philips
Page 3 · response
Published 5 November 2025

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

Clinical sites are responsible for governing alarm-configuration changes and ensuring staff respond to alarms under local policies and training.

Verbatim wording from the response

“made at the customer site after installation, nor do we maintain records of such changes or the authorization process for them. In this instance, it is unclear when the adjustment from medium to low priority was made or who authorized the change. It is the responsibility of the clinical site to ensure that any changes to alarm configurations are made in accordance with their internal governance and patient safety policies. Additionally, clinical staff are expected to acknowledge and respond to alarms in line with their training and local procedures, and to ensure that patients remain appropriately monitored. As mentioned in the Regulation 28 Report, Philips has reset the "ECG Leads Off" technical alarm to the factory default configuration [medium priority (yellow)], which better suits the needs of this hospital.”

Source location

Response from Philips
Page 3 · response
Published 5 November 2025

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 best placed to address monitor safety concerns and issue any necessary device safety bulletin.

Verbatim wording from the response

“NHS England would advise that the Medicines and Healthcare products Regulatory Agency (MHRA) would be best placed to respond to these concerns. The MHRA would also be in a position to issue a Device Safety Information bulletin, if required, to advise NHS organisations of the current risk and to update on the steps taken by the manufacturer (Philips) to implement the monitor reconfiguration and the new ‘yellow alert’ system.”

Source location

Response from NHS England
Page 1 · response
Published 5 November 2025

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.1

  1. 1

    Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share key learning across NHS England’s national and regional structures.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 5 November 2025.

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 Prevention of Future Deaths reports through the Regulation 28 Working Group and share key learning across NHS England’s national and regional structures.

Verbatim wording from the response

“I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Melanie, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.”

Source location

Response from NHS England
Page 2 · response
Published 5 November 2025

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

Official responses located
3/3

Data last updated 7 September 2026