Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0529, written 17 Oct 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 Oct 2025 |
|---|---|
| Reference | 2025-0529 |
| Deceased | Melanie Walker |
| Coroner | Timothy Brennand |
| Coroner area | Manchester (West) |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Secretary of State for Health and Social Care. House of Commons London SW1A 0AA 1. 2. Chief Executive NHS England NHS England, PO Box 16738, Redditch, B97 9PT 3. M Medical Engineer Philips Electronics UK Ltd Ascent 1, Aerospace Boulevard, Farnborough, GU14 6XW. 1 CORONER I am Timothy William Brennand, HM Senior Coroner, for the coroner area of Greater Manchester (West) 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On the 2nd day of January 2025, I commenced an investigation into the death of MELANIE JAYNE WALKER, Aged 43 years. The investigation concluded at the end of the inquest on the 14th of October 2025. The medical cause of death was: - 1a Combined Drug Toxicity ) The conclusion of the inquest was a short form conclusion of ‘Drug related’ death. 4 CIRCUMSTANCES OF THE DEATH The deceased had a complex medical history that included co-occurring established diagnoses of Bi-Polar Affective Disorder, recurrent episodic low mood, anxiety and depression with long standing drug and alcohol dependency syndrome. She had received active community-based treatment and care by local mental health and addiction service providers that had also included previous voluntary and involuntary in-patient phases of hospitalisation pursuant to the provisions of the Mental Health Act 1983. In 2024, the deceased was in a phase of progressive deterioration with a nuanced relapse profile triggered by her personal circumstances and remission into recreational drug misuse as a coping mechanism. She had become non-concordant with her prescribed depot medication, that exacerbated her deterioration. By October 2024, her depot and lithium medication had been replaced with Olanzapine – an anti-psychotic medication with which she had become concordant. Between the 9th and 17th of December 2024, for reasons that remain unclear, the deceased had relapsed and reverted to recreational drug misuse, . On the evening of the 17th of December 2024, following concern for her welfare, the deceased was eventually discovered on Trafford Street, Farnworth in a collapsed and partially responsive condition and admitted to the Royal Bolton Hospital, Minerva Road, Farnworth. Her admission urine screening test showed the presence of . She was treated in the Resuscitation Department where she was monitored and observed actively between her admission and 4am – her clinical observations being stable. At 4.45 am she was discovered collapsed and unresponsive on the trolly within her cubicle and found to be in cardiac arrest – but as this event had not been monitored or directly observed, the downtime of her cardiac arrest cannot be established, but was sufficient for her to sustain an irreversible hypoxic brain injury. Nursing staff were unable directly to observe the deceased by reason of an operational emergency concerning another patient within the Resuscitation Department. The evidence also established that the electrical monitoring equipment did not trigger any alarm from her heart monitor for reasons that cannot be established precisely, but were considered to be associated with the consequence her earlier attempts, in a state of confusion and agitation, of her observed efforts to remove the electronic monitoring devices attached to her, combined with a sub-optimal operational design that gave rise to the inadvertent disconnection of the monitoring equipment that had not been appreciated by clinical staff. Once her cardiac arrest was diagnosed, she was resuscitated and was to return to spontaneous circulation, albeit she was profoundly unconscious. Despite optimal care, she failed to show improvement or recovery of her neurological function. Repeated CT imaging of her brain showed no reversible cause of her loss of neurological function. After nine days of observation, with family consent, she had her life support withdrawn and she subsequently died on the 26th of December 2024. The evidence established her cardiac arrest to have been caused by a recognised complication of the combined toxicity of both previous and recent self-ingested illicit cocaine and benzodiazepines but the precise quantity, concentration, time and circumstances of the recent ingestion prior to her hospitalisation cannot be established, but is likely to have been at recreational or therapeutic levels, in keeping with her recognised relapse profile associated with her complex mental ill health and co-occurring illnesses. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – 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) the 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 cerates 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. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you and/or your organization have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 28th November 2025. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise, you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons; 1. 2. 3. Son , Mother , Chief Executive of Bolton NHS Trust I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any other person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response. 9 Dated: 17/10/2025 Timothy William BRENNAND Senior Coroner for Manchester West
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Parliamentary Under-Secretary of State 39 Victoria Street London SW1H 0EU HM Coroner Timothy Brennand Coroner’s Office Manchester West First Floor Paderborn House Howell Croft North, Bolton BL1 1QY 29 January 2026 Dear Mr Brennand, Thank you for the Regulation 28 report of 17/10/2025 sent to the Secretary of State about the death of Melanie Walker. I am replying as the Minister with responsibility for Medical Technology. Firstly, I would like to say how saddened I was to read of the circumstances of Melanie Walker’s death and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Please accept my sincere apologies for the delay in responding to this matter. The report raises concerns over the following areas: • The heart monitor in use did not alert clinicians that a patient had experienced a cardiac event. • The heart monitor became disconnected from the patient and was not identified by staff as it did not ‘re-alert’ where staff had acknowledged an abnormal reading. • The heart monitor in its current configuration may encourage the erroneous assumption by healthcare staff that a patient is being appropriately monitored when they are not. In preparing this response, my officials have made enquiries with the Medical and Healthcare products Regulatory Agency (MHRA) to ensure we adequately address your concerns. The setting of the patient monitor to not continuously alarm in the case of disconnection from the patient, combined with the staff expectation that it would do so, is the central event I wish to address. Philips has already stated that it is the factory default for these devices that the ‘leads off’ alert is set to ‘alarm on’. Therefore, our response is based around ensuring users understand that these devices can be set to ‘alarm off’, and must be confirmed as being ‘alarm on’ when intended to be used in that manner. In addition to its own response to your report in November 2025, Philips also issued a Field Safety Notice for users of their IntelliVue line of Patient Monitors. This highlights that alarm function is user reconfigurable, and should hence be confirmed in use to ensure it is not accidentally left in the ‘alarm off’ state. Following its standard practice, the MHRA has published the document on its gov.uk platform, ensuring users across the healthcare system have access to this information. 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. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, Parliamentary Under-Secretary of State for Health Innovation and Safety
Timothy William Brennand
HM Senior Coroner
Greater Manchester (West) Coroner’s Office,
Manchester West,
First Floor,
Paderborn House,
Howell Croft North,
Bolton
BL1 1QY
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
17 December 2025
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Melanie Jayne Walker
who died on 26 December 2024.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17th
October 2025 concerning the death of Melanie Jayne Walker on 26th December 2024.
In advance of responding to the specific concerns raised in your Report, I would like
to express my deep condolences to Melanie’s family and loved ones. NHS England is
keen to assure the family and yourself that the concerns raised about Melanie’s care
have been listened to and reflected upon.
I am grateful for the further time granted to respond to your Report, and I apologise for
any anguish this delay may have caused Melanie's family or friends. I realise that
responses to Coroners’ Reports can form part of the important process of family and
friends coming to terms with what has happened to their loved ones, and I appreciate
this will have been an incredibly difficult time for them.
Your Report raised concerns about the heart monitoring machine used for Melanie on
17 December 2024. You were concerned that the electrical monitoring equipment did
not trigger any alarm from Melanie’s heart monitor, when it should have done. You
raised the risk that where a blue ‘in op’ alert is triggered by an event such as an
abnormal reading or a monitor lead becoming disconnected, staff are not re-alerted
once the original alert has been acknowledged through pressing a button, even if an
issue such as disconnection remains. You considered this risk remains an issue for all
Hospital Trusts nationally.
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.
NHS England’s North West regional colleagues have engaged with Greater
Manchester Integrated Care Board (ICB), who have advised that the learning from the
Patient Safety Incident Investigation has been shared via the Speciality and Divisional
Governance structures and via Trust Governance structures, which include the
Medical Devices Committee, Quality Assurance Committee and Patient Safety Group.
The ICB has advised that in an area such as resuscitation, monitoring is continuous,
as the patients are on telemetry monitoring. It would be normal practice for patients
not to be directly observed over short periods, depending on their individual clinical
trajectory. Melanie’s clinical trajectory was that of improvement, as she had been
stable for over 3 hours with overall improvement. It was felt that the key safety action
was the reconfiguration of the alarm system, which would then alert staff if any leads
had become dislodged or removed.
Greater Manchester ICB has also advised that, regarding the reconfiguration of
alarms, the monitors have since been reconfigured. Now, when an ‘ECG leads off’
alarm is generated, the monitor will give the visual yellow flashing banner. If the alarm
is acknowledged, the yellow banner will remain and the audio will re-alarm after three
minutes if the ECG leads are still not connected, whereas previously the monitor would
‘blink’ only and would not alarm.
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.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
NHS England
HM Coroner’s Court and Office for Manchester West Paderborn House Howell Croft North Bolton BL1 1QY United Kingdom 17-Nov-2025 Dear Mr. Brennand, We acknowledge receipt of the Regulation 28 Report dated 17 October 2025, concerning the death of Melanie Jayne Walker. We wish to extend our sincere condolences to Ms. Walker’s family and all those affected by her passing. Philips takes matters of patient safety extremely seriously and is committed to working collaboratively with healthcare providers to continually improve the safety and effectiveness of our medical devices. We have carefully reviewed the matters of concern raised in Section 5 and the recommended actions in Section 6 of your report. We wish to provide the following information in response. The Philips IntelliVue product line provides a range of alarm configuration options designed to support the diverse workflows and clinical environments found in hospitals. The following table summarizes the available alarm priority settings within the IntelliVue family. Alarm Priority Display Description Visual alarm signals: • The black alarm text is displayed on a cyan background color on top of the screen rotating with other alarms. • A cyan alarm lamp is illuminated permanently. Low Auditory alarm signals: • An alarm tone conveying a low level of urgency is repeated every 2 seconds. Acknowledgment: • When alarm is acknowledged, alarm tone stops, and alarm lamp is switched off. • No auditory alarm reminder or re-alarm option. Visual alarm signals: Medium • The black alarm text is displayed on a yellow background color on top of the screen rotating with other alarms. Alarm Priority Display Description • A yellow alarm lamp blinks. Auditory alarm signals: • An alarm tone conveying a medium level of urgency is repeated every 2 seconds. Acknowledgment: • When alarm is acknowledged, alarm tone stops, and alarm lamp is switched off. • Auditory alarm reminder or re-alarm is available when configured. Visual alarm signals: • The white alarm text is displayed on a red background color on top of the screen rotating with other alarms. • A red alarm lamp blinks. High Auditory alarm signals: • An alarm tone conveying a high level of urgency is repeated every second. Acknowledgment: • When alarm is acknowledged, alarm tone stops, and alarm lamp is switched off. • Auditory alarm reminder or re-alarm is available when configured. The factory default configuration of the "ECG Leads Off" technical alarm is medium priority (yellow) and includes an alarm reminder. As depicted in the graphic below, after an alarm configured with an alarm reminder is acknowledged, the reminder will provide an audible beep every one, two or three minutes (configurable) for six seconds until the alarm condition is resolved. This factory default setting is designed to ensure that a disconnected lead generates a prominent and persistent visual and audible notification. Alarm Reminder Functionality The factory default configuration of the "ECG Leads Off" technical alarm can be adjusted to low priority (cyan) either during installation or at a later time by authorized hospital staff using a password-protected menu. This configuration can also be inherited if monitor settings are transferred from another device where the alarm was previously set to low priority (cyan). The ability to modify alarm settings is provided to allow clinical sites to adapt the system to their local protocols and operational needs. However, Philips does not have oversight or control over changes 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. 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. We remain committed to patient safety and to working collaboratively with our customers to support the effective use of our equipment and trust this satisfies your concerns. We are, however, open to further discussions with the Bolton NHS Trust and the wider NHS England to determine how we can support further. Should you have any further questions, please do not hesitate to contact me via email as indicated below. Sincerely, Director of Complaint Handling Operations Hospital Patient Monitoring and Regulatory Inquiries
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