Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0412, written 21 Jul 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 21 Jul 2025 |
|---|---|
| Reference | 2025-0412 |
| Deceased | Jean Dye |
| Coroner | Paul Smith |
| Coroner area | Greater Lincolnshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 NHS England 2 HSE 1 CORONER I am Paul D SMITH, HM Senior Coroner for the coroner area of Greater Lincolnshire 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 11 September 2020 I commenced an investigation into the death of Jean DYE aged 77. The investigation concluded at the end of the inquest on 02 July 2025. The conclusion of the inquest was that: Jean Dye died on 7 September 2020 at Scunthorpe General Hospital as a consequence of an iatrogenic artery dissection which occurred during Percutaneous Coronary Intervention to treat underlying cardiac disease. That was a rare but recognised complication of the procedure. Once the dissection was identified there was a limited opportunity to provide the necessary remedial treatment by the deployment of cardiac stents. Coincidentally at that moment there was a sudden and unexpected failure of electrical power within the treatment room which persisted for approximately 10 minutes. Save that it resulted from an activation of the Emergency Power Off (EPO) Circuit, which overrode the back up electrical supply, no clear cause of that loss of power was identified. There was no manual activation of the EPO buttons and a fault within the circuitry was suspected but not established to the required standard. The loss of electrical power removed the ability to provide x ray images and consequently prevented commencement of the stenting procedure until power was regained. Although the stenting was then completed Mrs Dye failed to recover and her death was confirmed. On balance of probabilities, Mrs Dye would have survived but for the loss of electrical power. 4 CIRCUMSTANCES OF THE DEATH Jean Dye died on 7 September 2020 at Scunthorpe General Hospital as a consequence of an iatrogenic artery dissection which occurred during Percutaneous Coronary Intervention to treat underlying cardiac disease. That was a rare but recognised complication of the procedure. Once the dissection was identified there was a limited opportunity to provide the necessary remedial treatment by the deployment of cardiac stents. Coincidentally at that moment there was a sudden and unexpected failure of electrical power within the treatment room which persisted for approximately 10 minutes. Save that it resulted from an activation of the Emergency Power Off (EPO) Circuit, which overrode the back up electrical supply, no clear cause of that loss of power was identified. There was no manual activation of the EPO buttons and a fault within the circuitry was suspected but not established to the required standard. The loss of electrical power removed the ability to provide x ray images and consequently prevented commencement of the stenting procedure until power was regained. Although the stenting was then completed Mrs Dye failed to recover and her death was confirmed. On balance of probabilities, Mrs Dye would have survived but for the loss of electrical power. Regulation 28 – After Inquest Document Template Updated 30/07/2021 5 CORONER’S CONCERNS During the course of the investigation my inquiries 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: (brief summary of matters of concern) The circumstances of Mrs Dye's death are set out above. Her death arose as a consequence of the combination of an iatrogenic injury sustained during a clinical procedure and an untimely loss of power to the Catheter Lab where she was being treated for a period of approximately ten minutes at exactly the time at which her treating consultant required the benefits of real time xray to facilitate a necessary emergency stenting procedure. The delay whilst power was restored was a critical factor in this death. The loss of power arose as a result of the Emergency Power Off (EPO) circuit activating. It overrode the emergency power back up system. The reason for that activation was unclear although a physical activation of any of the three EPO buttons was excluded on the evidence. All staff at the scene were unaware of the cause of the loss of power, never having experienced such a situation previously, and an engineer was summoned to attend to reinstate the power, which he did. There was no light or other indicator within the lab to confirm to those present that the EPO circuit had activated. Likewise there was no restart button within the lab to permit the EPO circuit to be reset. That lay within the plant room elsewhere within the hospital. I received evidence of a small number of accidental activations of EPO circuits nationally over a 12 month period. It is plainly something which can, and does, occur. Had staff been aware of the exact cause of the loss of power on this occasion and had they had the opportunity to reset the circuit without the need to await the arrival of an engineer, who inturn had to attend a separate plant room, the downtime would likely have been significantly reduced. Whilst it was not possible to say that the additional time spent on this occasion made a difference between the patient surviving or not, there may well be future cases within which such fine margins are time critical. I received evidence that there is no current guidance in relation to the siting of such controls remote from the affected room. I invite review of that guidance and of the need for any consequential training. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you (and/or your organisation) 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 August 28, 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. COPIES and PUBLICATION 8 I have sent a copy of my report to the Chief Coroner and to the following Interested Persons - Family – Capsticks representing NLAG – Eversheds-Sutherland representing GE Precision Healthcare Royal College of Radiographers Regulation 28 – After Inquest Document Template Updated 30/07/2021 MHRA I have also sent it to who may find it useful or of interest. 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 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 by the Chief Coroner. 9 Dated: 21/07/2025 Paul D SMITH HM Senior Coroner for Greater Lincolnshire Regulation 28 – After Inquest Document Template Updated 30/07/2021
2 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.
HM Senior Coroner The Coroners Courts & Office The Myle Cross Centre 92 Macaulay Drive Lincoln LN2 4EL 15 October 2025 Dear HM Senior Coroner (Mr Paul D Smith) Regulation 28 Report following the inquest into the death of Mrs Dye We are sorry to hear about the death of Mrs Dye and we offer our sincere condolences to her family. Care Quality Commission (CQC) first became aware of the death of Mrs Dye on receipt of the Regulation 28 Report to Prevent Future Deaths (the Report) on 25 July 2025. We understand the death occurred whilst Mrs Dye was receiving surgery at Scunthorpe General Hospital, which is a location of Northern Lincolnshire and Goole NHS Foundation Trust (the Trust), which is a CQC Registered Provider. CQC are named responders in the Report. We are grateful for the extension of time granted for our response to be provided, that being until 16 October 2025. In the Regulation 28 Preventing Future Deaths report the HM Coroner raised the following concerns: • Review of the guidance • Review of the need for any consequential training. Having considered the report and additional documentation provided, we understand the matters of concern to be as follows: • There is no current guidance in relation to the siting of Emergency Power Off (EPO) restart buttons remote from an affected room; review of such guidance is invited • Further, review of the need for any consequential training is also invited It is important to highlight from the outset that CQC does not have the power to set guidelines or training expectations, rather we assess a registered provider’s ability to meet regulatory requirements. Whilst assessing regulatory compliance can involve the application of relevant guidelines, it is not within the scope of CQC’s regulatory powers to set the guidelines or any associated training requirements. Whilst CQC are unable to provide further response in respect of whether specific guidance or training requirements should be implemented, we can set out what actions have been taken following receipt of the Report and our engagement with the Trust in this matter. CQC last undertook a comprehensive inspection of the Trust in June and July 2022. The CQC report was published in December 2022, and we rated the Trust as “Requires Improvement.” A copy of the report can be found on our website - Trust - RJL Northern Lincolnshire and Goole NHS Foundation Trust (02/12/2022) INS2- 12039916291 Following receipt of the Report, CQC engaged with the Trust and requested evidence of any action they had taken to date following the tragic death of Mrs Dye. The Trust responded by stating that at the time of the incident, the police had assumed primacy over the investigation and had later concluded that there was no criminality. The Trust have provided us with a copy of external independent reports completed in September 2020 and February 2024 on behalf of the police. The reports concluded that the treatment room power interruption was due to an unknown electrical fault, with no fault on the part of the Trust, its systems, or staff. At the time of the incident the Trust logged it as a serious incident on the Strategic Executive Information System (StEIS). However, this was later de-logged with agreement from the clinical commissioning group (CCG). This meant the Trust did not complete a serious incident investigation report. Subsequent external independent inspection reports were recommended by the Medicines and Healthcare products Regulatory Agency (MHRA). The reports from September 2020 and February 2024 concluded the fault was a rare event caused by an electrical fire within the EPO control room. The Trust has confirmed the following recommendations from this report and inquest have been actioned: • The EPO’s at Scunthorpe and Grimsby hospitals now have durable labels (x- ray system emergency power off) and photos were provided as evidence to the coroner • The Trust has an Electrical Safety Group which meets on a quarterly basis as recommended by the Health Technical Memoranda HTM 06-01 • The Trust has confirmed the installation reports have been completed in accordance with the relevant guidelines In relation to the installation of remote on/off buttons with integral lamps the Trust discussed this at a governance meeting in April 2025. They also added that there is no current guidance requiring this, which was also highlighted by the independent engineer. CQC will continue to monitor the Trust as part of our regulatory activity. We hope that our response addresses your concerns in so far as we are able to. If we can provide any further information, then please do not hesitate to contact us. Yours sincerely Deputy Director of Operations Network North
Mr Paul D Smith
HM Senior Coroner
Lincolnshire Coroner’s Service
The Myle Cross Centre
92 Macaulay Drive
Lincoln
LN2 4EL
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
13 October 2025
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Jean Dye who died on 7th
September 2020.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 21st
July 2025 concerning the death of Jean Dye on 7th September 2020. In advance of
responding to the specific concerns raised in your Report, I would like to express my
deep condolences to Jean’s family and loved ones. NHS England is keen to assure
the family and yourself that the concerns raised about Jean’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 Jean'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 that there is no current guidance for the siting of
Emergency Power Off (EPO) controls, particularly where there are remote from the
affected room. In this case, the EPO was not sited within the lab nor was there a restart
button in the lab to allow the EPO to be reset - this was in another room located
elsewhere within the hospital. You invited a review of the guidance and of the need for
any consequential training.
Review of the guidance
There are currently two guidance documents that reference EPO controls. They are
the Health Technical Memorandum (HTM) 06-01 Electrical services supply and
distribution and the Health Building Note (HBN) 01-01: Cardiac facilities.
HTM 06-01 Electrical services supply and distribution (published in 2007 and updated
in January 2024) refers to EPOs:
“Emergency power off switches
15.59 Some permanently installed (fixed) ME [medical electrical] equipment,
according to the manufacturer’s instructions, require emergency power off
(EPO) mushroom buttons to be provided. These switches are intended to
remove all power in the event of a serious incident such as fire, flood or electric
shock, which is very rare. It is important to protect these switches from
accidental operation, such as an operator leaning on the button or a trolley
pushed against it.
15.60 Protection against accidental operation of the EPO can be achieved by
careful positioning of the button and using one fitted with a shroud (often a semi-
circular protrusion over the top). Care should be taken to avoid making the
button too difficult to operate; therefore, covers that need to be lifted should be
avoided.
15.61 The EPO button(s) may require a double-pole contact to enable two
circuits to be formed. One will remove the power to the equipment supply
contactor and the other circuit may be needed to shut down any UPS
[uninterruptible power supply] the system is using in order to fully isolate the
source of power.
15.62 EPO buttons should also be clearly marked (labelled) to indicate their
function and the related equipment. For example, “X-ray system Emergency
Power Off”.”
This guidance is focused on stopping accidental activation of the EPO, but does not
currently state what to do if the EPO is activated in error. The NHS England Estate’s
team advise that they will address this when the HTM 06-01 guidance document is
next updated.
NHS England’s Head of Hard Facilities Management has been contacted by an
independent advisor to the Medicines and Healthcare products Regulatory Agency
(MHRA) on electrical safety, who was involved in the inquest hearing. The MHRA
advisor raised that:
• The EPO control itself does not need to be in the same room as the
equipment/users, just a means to reset it;
• A risk assessment on power failure needs to be conducted as part of the room
design;
• He has suggested the following wording be used in the HTM 06-01 guidance
when it is rewritten:
“All EPOs and associated contacts in the EPO circuit should as a minimum, be
replaced when an interventional x-ray room is replaced and would suggest this
is common practice with all medical radiological equipment.
All interventional x-ray rooms shall be inspected and if the contactor is in
another location, (operator cannot see the on/off buttons from the x-ray room),
a remote on/off is fitted. The remote on/off buttons shall have integral lamps.”
Guidance on cardiac catheter labs, the setting for this incident, are covered in HBN
01-01 “Cardiac facilities”. The current version of HBN 01-01 was published in 2013
(updated in January 2024) and includes the following references to power:
“Catheter laboratories
5.9 Key engineering considerations include:
… It is recommended that removal of a catheter under X-ray control is possible
in the event of mains power failure; this requirement should be discussed with
the hospital’s and system manufacturer’s engineers.”
Earlier guidance, published in 2001 by the former NHS Estates (an Executive Agency
of DHSC abolished in 2005) called HBN 06-01 “Facilities for diagnostic imaging and
interventional radiology” is in the process of being updated, but excludes cardiac
facilities covered separately in HBN 01-01. The draft updated HBN 06-01 currently
includes the following text on EPO buttons:
6.62 As set out in HTM 06-01, emergency stop buttons should be provided
within imaging examination rooms. There are three main types of emergency
button (see AXREM emergency stop button label recommendations):
• emergency power-off – cuts mains power and mains power UPS to the
•
whole room
imaging system emergency power-off (also medical equipment emergency
power-off) – cuts power on a local control circuit specific to particular item(s)
of medical equipment. For example, the X-ray system emergency power-off
button would cut power to the X-ray machine and its local equipment UPS
to ensure X-rays cannot be generated in an emergency situation. The mains
power to the room would remain on so that items on separate circuits such
as lights and IT would stay on
• emergency motion stop – stops movement on the imaging equipment in the
event of an emergency, to prevent harm to patients.
6.63 Emergency-stop switches should be clearly labelled, easily accessible
by staff and mounted at a height which reduces the risk of accidental use. They
should be installed in both the examination and control area, with advice sought
from the RPA [radiation protection advisor] or MRSE [magnetic resonance
safety expert] (as appropriate) on button locations.
As a result of the discussions between the Head of Hard Facilities Management and
the MHRA advisor, amendments are to be made to this text. The amendments will
also address the location of reset buttons in the update.
An update to HTM 06-01 is planned and the content relating to EPOs will be reviewed
in light of this incident and the final published content for HBN 06-01, to ensure
alignment of guidance. The update is due to be completed in the financial year 2026-
27.
Training
Competency and training for engineers will be included in the HTM update described
above.
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 Jean,
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
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