Product related deaths

PFD Category
Reports: 131 Areas: 54 Earliest: Oct 2013 Latest: 5 Aug 2025

77% response rate (above 63% average). 31% of classified responses show concrete action taken. Reports rose 150% from 6 (2023) to 15 (2024).

PFD Reports
81 results
Karlton Donaghey
All Responded
2023-0399 23 Oct 2023 Newcastle upon Tyne and North Tyneside
Product Safety and Standards
Concerns summary (AI summary) Helium balloons are freely available without adequate warnings, and parents lack sufficient awareness of the significant risks they pose to young children.
Action Planned (AI summary) OPSS will write to the British Standards Institution to recommend updating the Toy Safety Standard EN71 to reflect the risks of helium inhalation. OPSS will also write to relevant trade organizations and Local Authority Trading Standards authorities advising them of OPSS’ concerns about the risks posed by helium-filled balloons.
Mizanur Rahman
All Responded
2023-0306 29 Aug 2023 Inner North London
Product Safety and Standards
Concerns summary (AI summary) A lack of British or European safety standards for lithium-ion e-bike batteries and chargers allows unsafe products to be sold and mixed, causing fires, thermal runaway, and multiple deaths.
Action Taken (AI summary) The Office for Product Safety and Standards has engaged with the London Fire Brigade and Tower Hamlets Trading Standards, established a multi-disciplinary safety study, commissioned research into battery safety, and published consumer information on safe e-bike practices.
Mackenzie Cooper
All Responded
2023-0431 13 Jul 2023 Nottingham City and Nottinghamshire
Central England Co-operative Department of Health and Social Care
Concerns summary (AI summary) A community defibrillator was supplied in a non-workable state due to missing parts, highlighting inadequate maintenance systems and poor staff communication. A national system for defibrillator status is also lacking.
Action Planned (AI summary) A review has been conducted and certain improvements have been or are shortly to be made to the system operated by Central England Co-operative Limited, and further discussions with The British Heart Foundation will take place in due course in the interests of a wider positive impact. The Government has provided funding of £1m for a grant scheme to buy life-saving defibrillators for community spaces, which launched in September 2023. All Automatic External Defibrillators (AED’s) granted by the fund must be registered on The Circuit – The British Heart Foundation’s national defibrillator database which is synchronised with the Computer Aided Dispatch systems of the 14 Ambulance Trusts in the UK and holds the location and where required access codes for defibrillators.
Chester Mossop
All Responded
2023-0127 20 Apr 2023 Cumbria
Office of Product Safety and Standards
Concerns summary (AI summary) The report expresses concern that bath seats may give parents a false sense of security and that parents/carers may not be provided with advice about the safe use of bath seats.
Action Planned (AI summary) OPSS will assess the safety and compliance of similar baby bath seat models and work with the Baby Products Association to reinforce requirements for safe use instructions and clear safety warnings; they will also engage with the NHS to explore incorporating safety messages related to baby bath seats. NHS England will update its ‘Washing and bathing your baby’ website page with guidance on the use of bath seats, highlighting that they are not recommended by RoSPA or the Child Accident Prevention Trust, and is undertaking a communications push to highlight the importance of never leaving babies of any age unsupervised while in the bath; OHID will be raising the case with their networks as a safety alert.
Carol Welch
All Responded
2023-0011Deceased 11 Jan 2023 Warwickshire
George Eilot Hospital NHS Trust
Concerns summary (AI summary) Inadequate training and assessment processes failed to ensure doctors, especially those trained overseas, were familiar with Royal College guidance for returning ED patients and investigating neurological findings like subarachnoid haemorrhage, with learning not effectively embedded.
Action Planned (AI summary) The Trust is adding an alert to the Clinical Portal used by UEC to flag/highlight if a patient reattends within 72 hours and mandate that the doctor should seek advice from a consultant prior to discharging the patient from the department. UEC are in the process of conducting an audit to review patients that have reattended within 72 hours to see whether they were referred to a consultant prior to discharge.
Reginald Cauthery
All Responded
2022-0326 4 Oct 2022 Inner North London
CECOPS Care Quality Commission Department of Health and Social Care +3 more
Concerns summary (AI summary) A vulnerable person's telecare service was not reviewed despite increased fire risk, and smoke alarms were not connected to telecare, delaying emergency fire brigade notification.
Noted (AI summary) The TEC Services Association (TSA) will issue guidance to certified monitoring organizations by the end of November 2022. They also plan to develop a Fire Call Handling Pathway Decision Support Tool with the support of NFCC and LFB, but anticipate it will not be available until 2024. The CQC acknowledges the concerns but states they relate to services outside their scope of regulation (fire service and telecare service) and therefore they have no powers to prevent future deaths in relation to these services. The Department of Health and Social Care has reminded local authorities to consider technology-enabled care in maintaining independence and linking preventative devices like smoke detectors. It also published an updated Adult Social Care Digital Skills Framework to support the development of digital skills across the adult social care workforce. The Home Office will share information from the case with the National Fire Chiefs Council (NFCC) and encourage them to disseminate findings and highlight the importance of linking telecare systems to smoke alarms during fire safety checks. The London Borough of Hackney will address its procedures and guidance within its 'Mosaic' system to reduce risks to vulnerable individuals, especially regarding fire safety for those with risk factors like being bed-bound and a smoker; a table detailing planned actions and timelines is attached. The organisation recommends monitored smoke detectors and rapid heat detectors for elderly and vulnerable service users, referencing recommendations made with London Fire Brigade in 2003.
Edward Capovila
All Responded
2022-0125 25 Apr 2022 County of Cumbria
Medicines and Healthcare products Regul…
Concerns summary (AI summary) Insufficient information regarding unusual methods of fentanyl misuse poses a significant risk of future deaths due to its potential for varied abuse.
Action Taken (AI summary) The MHRA issued a drug safety bulletin in 2014 warning of overdose risk with fentanyl patches exposed to heat. In 2019, they reviewed benefits/risks and made recommendations for regulatory action, including updated warnings about addiction in product information and a Drug Safety Update article. The product information for all licensed codeine medicines is being updated.
Emma Pring
All Responded
2022-0105 3 Apr 2022 Mid Kent and Medway
Interweave
Concerns summary (AI summary) "Anti-ligature" safety clothing failed, allowing self-harm and potentially providing staff with false reassurance. Older, riskier versions of the product remain in circulation, requiring urgent action.
Action Taken (AI summary) Interweave Textiles Ltd. notified customers who had been supplied with similar products, recommending they check their stock for damage and reminding them to check garments before use and dispose of damaged ones, as well as reviewing and updating care instructions.
Anthony Walgate, Gabriel Kovari, Daniel Whitworth and Jack Taylor
All Responded
2022-0017 21 Jan 2022 East London
Metropolitan Police Service, National P…
Concerns summary (AI summary) Police investigations were marred by a significant number of "very serious and very basic investigative failings," including a profound lack of curiosity and errors, with terrible consequences.
Action Planned (AI summary) The NPCC and College of Policing outline actions taken, including updating the Death Investigation Manual and associated training to emphasize treating deaths as suspicious until proven otherwise. They have also highlighted existing guidance on handling personal effects and assessing handwritten notes, and initiated a review of the Forensic Submissions Good Practice Guide. DCMS states that the Online Safety Bill will place new requirements on companies in relation to illegal content and anonymity online and services will have to identify, mitigate and effectively manage the risk of anonymous profiles. Ofcom will set out the types of verification methods a company could use in guidance. The Metropolitan Police Service has updated its Death Investigation Policy to emphasize treating deaths as suspicious until proven otherwise and is providing refresher training to detectives. The CONNECT Investigation platform, which is replacing CRIS, will have improved functionality to track the completion of investigative actions.
Yousef Makki
All Responded
2021-0434 31 Dec 2021 Greater Manchester South
Department for Education
Concerns summary (AI summary) The coroner notes a culture among some teenagers of viewing knife possession as impressive without understanding the risks, and that the knife used in the stabbing was easily purchased during school break time, highlighting the vital role of schools and education in addressing attitudes towards knife carrying.
Action Planned (AI summary) The Department for Education is investing in educational resources to address knife crime and serious youth violence, and investing £45 million in two new programmes including Alternative Provision Specialist Taskforces and the SAFE Taskforces programme.
Jonathan Bayliss
All Responded
2021-0413 7 Dec 2021 North West Wales
Ministry of Defence
Concerns summary (AI summary) Urgent investigations into an artificial stall warning for the Hawk Mk 1 aircraft, which can stall without warning, are stalled. The training simulator also inaccurately models the aircraft with a smoke pod.
Action Planned (AI summary) The MOD is undertaking investigations into incorporating an artificial stall warning capability in the Hawk T Mk1, with a decision expected in summer 2022. The RAF is developing options for a RAFAT-focused Hawk Synthetic Training Facility, expected to be in place by 2025, and will update the current Hawk Synthetic Training Facility software to reflect a RAFAT aircraft by 2023.
Darrell Devlin
All Responded
2021-0397 23 Nov 2021 Cumbria
Greater Manchester Mental Health NHS Fo…
Concerns summary (AI summary) Over-reliance on remote drug and alcohol service contacts without in-person assessments or drug testing led to inaccurate client assessment, risking harm from excessive dosage or polydrug exposure.
Noted (AI summary) Humankinds, the incoming provider of Addictions Services within Cumbria, describes actions already taken since taking over the service, including weekly provider meetings, clinical handover for high-risk cases, data transfer of all active service user’s relevant information, and review of all service users at a face-to-face appointment. Greater Manchester Mental Health (GMMH) acknowledges the concerns and apologizes, highlighting that the death occurred during the COVID-19 pandemic, and refers to a meeting with the new service provider, Humankind, regarding the transfer process. GMMH offers to meet with the coroner to discuss the transfer of services.
Grand Canyon
All Responded
2021-0392 18 Nov 2021 West Sussex
Civil Aviation Authority
Concerns summary (AI summary) Current regulations for Crash Resistant Fuel Systems (CRFS) in rotorcraft are inadequate, failing to mandate retrofits or provide a public register. This leaves a high risk of post-crash fires and prevents informed public decision-making.
Action Planned (AI summary) The CAA is considering safety proposals for existing Rotorcraft on the UK register to be incorporated into the aviation legislation and policy rulemaking programme. They will also implement a targeted promotion strategy to the Rotorcraft aviation community, and encourage owners to enhance safety voluntarily. The CAA will review UK aviation safety data, monitor developments from EASA RMT.0710, contact the FAA, and consider rule changes. It will provide a supplemental report by 31st July 2022.
Aaron Fretwell
All Responded
2021-0331 5 Oct 2021 West Yorkshire (East)
Bailey Trailers Ltd
Concerns summary (AI summary) An agricultural trailer lacked a required propping device and warning signs, failing to meet safety regulations. Many similar trailers remain in use without these critical safety features, posing a risk of future accidents.
Action Taken (AI summary) The company now fits a mechanical body support to secure the body in a high position during maintenance to all applicable trailers; its revised operation and maintenance manual states how to deploy it and warns users to never work under a raised body unless propped, and has emailed dealers to explain the design does not require the trailer to be raised for routine maintenance.
Mary Land
All Responded
2021-0322 29 Sep 2021 West Yorkshire (East)
Department of Health and Social Care Mid Yorkshire Hospitals NHS Trust Philips Respironics
Concerns summary (AI summary) The Philips Respironics AF 541 mask uses an insecure 'push-on' connection to the ventilator, prone to detaching, especially with a filter. A more robust docking mechanism is needed to prevent inadvertent disconnections.
Disputed (AI summary) The Mid Yorkshire Hospitals NHS Trust has already completed four actions identified in an RCA investigation, including scoping improvements for securing tubing circuit connections. They continue to use filters per BTS guidance, and note the manufacturer is addressing all-in-one circuit availability. The MHRA will agree an investigation plan with Philips Respironics, engage with them on standards compliance, and discuss updating guidance with the British Thoracic Society and NICE. They will also continue to assess incoming data and take action as needed. Philips Respironics argues that the AF541 mask design meets standards, is not intended to prevent disconnection, and is contraindicated for life support. They state the facility failed to follow instructions and incorrectly used an unapproved filter, leading to the incident, therefore no action is proposed. The Department of Health and Social Care acknowledges the MHRA's actions, including requesting a final investigation report from Phillips Respironics and discussions with the British Thoracic Society and NICE on updated guidance. It also mentions the Care Quality Commission (CQC) is monitoring the Mid Yorkshire Hospitals NHS Trust action plan.
Antony Schofield
All Responded
2021-0324 27 Sep 2021 Manchester City
Greater Manchester Mental Health NHS Tr…
Concerns summary (AI summary) Inadequate risk assessments, poor communication during patient transfer, and a lack of professional curiosity by community mental health staff led to missed opportunities to address escalating suicidal risk, compounded by poor audit and flawed investigation.
Action Taken (AI summary) Greater Manchester Mental Health NHS Foundation Trust has updated its process for obtaining staff statements following a Serious Incident, and has addressed factual inaccuracies with the RCA investigation author. They ensure all Serious Incidents are reviewed by a team supported by a Patient Safety Practitioner and that the final draft is shared with senior managers.
William Buchanan
All Responded
2021-0300 1 Sep 2021 Dorset
Department of Health and Social Care
Concerns summary (AI summary) Elderly individuals can acquire mobility scooters without any assessment of their suitability or competence to use them, posing a significant safety risk.
Noted (AI summary) The Department for BEIS acknowledges the report but asserts that existing product safety regulations are adequate for mobility scooters. They argue that placing an obligation on individuals to undertake an assessment before purchasing specific products would be disproportionate and propose that no further action is taken.
Ann Geraghty
All Responded
2021-0288 27 Aug 2021 Birmingham and Solihull
Philips Electronics UK Ltd
Concerns summary (AI summary) Cardiac monitors' alarms self-terminate upon rhythm correction, failing to alert staff to serious, self-resolving events like ventricular standstill, and the manufacturer has not provided a solution.
Disputed (AI summary) Philips Healthcare investigated the reported incident and concluded that the device operated per specification, that there is not a configuration available to enable asystole or any other red arrhythmia alarm to self-terminate, and that termination of asystole or other red arrythmia alarm with the current configuration requires end user intervention. University Hospitals Birmingham NHS Foundation Trust will provide refresher training to nursing staff on the alarm systems, explore altering the software configuration with Philips, and explore the retention of trace logs locally for an extended period.
Pauline Allison
All Responded
2021-0269 3 Aug 2021 West Sussex
British Medical Association and Sussex …
Concerns summary (AI summary) Insufficient awareness among patients, families, and carers about the increased fire risk from flammable emollient creams, especially when combined with air mattresses, poses a significant safety concern.
Noted (AI summary) NHS Brighton & Hove CCG, NHS East Sussex CCG, and NHS West Sussex CCG have reviewed preventable deaths messaging related to flammable products and are raising awareness of the risks from emollient creams, including publishing warnings and providing information to GPs, care homes, and patients about the fire risks associated with these products, based on previous alerts from the MHRA. The BMA acknowledges the concern about patient awareness of risks associated with emollient creams, but states they are not the appropriate organisation to address it. They suggest contacting the MHRA, NHS England, the Royal College of General Practitioners, and medical defence bodies instead.
Andrew Cook
All Responded
2021-0258 18 Jun 2021 Northamptonshire
Medicines and Healthcare products Regul…
Concerns summary (AI summary) Concerns involve potential under-reporting of PEG allergy, insufficient research into its effects, and the lack of clear labelling on medical products regarding PEG's presence, dose, and various synonyms.
Action Planned (AI summary) The MHRA will discuss labelling requirements with other regulators internationally, collect and review information from a range of data sources on PEG exposure, and raise the profile of PEG/macrogol working with relevant stakeholders where appropriate.
Emiel Malinski
All Responded
2021-0198 10 Jun 2021 Manchester South
Home Office
Concerns summary (AI summary) Miniature rifle ranges operate with minimal regulation, lacking essential safety measures such as secure weapon tethering, competent supervision, ammunition control, and first aid provisions.
Action Planned (AI summary) The Home Office is reviewing the firearms licensing exemption for miniature rifle ranges, prompted by the incident. They conducted a public consultation on tightening controls and will consider the responses before deciding on further measures.
Nicholas O’Brien
All Responded
2021-0197 9 Jun 2021 Hampshire, Portsmouth and Southhampton
British Kite Surfing Association
Concerns summary (AI summary) A kite-surfing radio device adhered to a helmet failed to detach when entangled, preventing depowering and leading to a fatal dragging incident. The device's attachment method was insecure, posing risks for similar helmet-mounted accessories.
Action Taken (AI summary) The British Kitesports Association issued recommendations to schools using BB-Talkin headsets or similar devices, including following manufacturer's instructions, checking equipment, making students aware of potential entanglement, and including guidelines in their Safety Management Systems.
Peter Hussey
All Responded
2021-0115 19 Apr 2021 Stoke-on-Trent & North Staffordshire Coroner’s Court
Enteral (GB) UK, University Hospital of… MHRA NHS Supply Chain
Concerns summary (AI summary) An enteral feeding and drainage tube's product description and staff training were insufficient, leading to confusion about its reduced bore size. This caused inadequate drainage, and the product is still misleadingly promoted.
Action Planned (AI summary) NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training procurement framework. GBUK Enteral Ltd has revised device labelling and Instructions For Use (IFU) to remove references to drainage, add warnings about flow restrictions with ENFit connectors, and clarify the intended use as a feeding tube. They have also provided refresher training to sales staff and requested NHS supply chain to update the device description on their website. The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance and a competency and self-assessment document. The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment and is collaborating with NHS England and Improvement on raising awareness on the Medical Devices Safety Officers' (MDSO) network.
Stephen Oakes
All Responded
2021-0114 19 Apr 2021 Stoke-on-Trent & North Staffordshire Coroner’s Court
Enteral (GB) UK, University Hospital of… Industry Groups Supply Chain Stakeholders
Concerns summary (AI summary) Product description for a 14Fr feeding/drainage tube was misleading due to a restrictive connector, leading to inadequate drainage. Hospital evaluation was insufficient, and staff lacked training on product changes and alternative actions.
Action Planned (AI summary) The manufacturer has updated the product labelling for the Carefeed devices to remove the secondary intended use of drainage; MHRA will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment and is collaborating with NHS England and Improvement on raising awareness on the Medical Devices Safety Officers' (MDSO) network. GBUK has revised device labelling and instructions for use, removing all references to drainage and adding warnings about flow restrictions with ENFit connectors and has provided refresher training to its sales force regarding nasogastric feeding tubes and ENFit connectors. The Trust has designed a new proforma for evaluating equipment and has updated the Trust e-learning training package for the insertion and on-going management of Nasogastric/Orogastric tubes including troubleshooting guidance and a competency and self-assessment document. NHS England and Improvement are working with the Healthcare Safety Investigation Branch (HSIB) testing and introducing national patient safety incident investigation training and developing a patient safety incident investigation training procurement framework.
Lynn Hadley
All Responded
2021-0346 18 Jan 2021 Black Country Area
Medicines and Healthcare Products Regul…
Concerns summary (AI summary) Oxygen cylinder regulators present an ignition risk, possibly due to incorrect valve operation by paramedics lacking knowledge of safety protocols, with multiple reported incidents despite no identified device defects.
Noted (AI summary) West Midlands Ambulance Service took immediate action by informing all frontline staff of requirements for medical gas cylinder assembly/disassembly and sharing lessons learned with partner organizations. The CQC acknowledges the concerns but states it is outside of their remit to issue or change formal guidance or policies around oxygen usage or safety, as they are not clinical experts. They will continue to communicate with WMAS and monitor actions taken to improve safety. HSE will support MHRA as the lead authority and will use its communication channels to promote any information/guidance produced by the MHRA. They will also consider if HSE guidance document INDG459 should be updated to reflect any new information/guidance produced. MHRA has commenced a dialogue with the Association of Anaesthetists and the Safe Anaesthesia Liaison Group of the Royal College of Anaesthetists to raise awareness of ignition within valve components of oxygen cylinders. MHRA was represented on a multiagency group which hopes to publish guidance once ratified by the Councils of both the RCoA and the AA.