Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0185, written 3 Jun 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 Jun 2019 |
|---|---|
| Reference | 2019-0185 |
| Deceased | Jeanette Robinson |
| Coroner | Andrew Cox |
| Coroner area | Cornwall and the Isles of Scilly |
| Category | Community health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS Jeanette Ann Robinson, deceased REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Fd Service Director, Transformation and Commissioning, Adult Social Care and Health, Cornwall Council 2. [HEE Medicines and Healthcare Products Regulatory Agency, 10 S. Colonnade, Canary Wharf, London E144 PU CORONER | am Mr Andrew Cox, Acting Senior Coroner for the coroner area of Cornwall and the Isles of Scilly. CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 5/1/17, an inquest was opened into the death of Jeanette Ann Robinson who died on 21/12/16 at Royal Cornwall Hospital Truro. At post-mortem, the cause of death was identified as: 1A) systemic sepsis (coagulase-negative staphylococcus and mixed anaerobic organisms) 1B) infected sacral decubitus ulcer (operated) 1C morbid obesity and diabetes mellitus (type I!) Il) frailty On 24/5/19, | concluded an inquest into the death of Mrs Robinson and recorded a narrative conclusion namely, that she died as the result of an accident. An unsuccessful attempted transfer into a community hospital contributed to the outcome. CIRCUMSTANCES OF THE DEATH | found that Mrs Robinson was a lady with a number of health issues that included morbid obesity and type II diabetes mellitus. She suffered a fall on or about 30/10/16 which reduced her already limited mobility. There was a delay in referring her to the district nurse team. Mrs Robinson developed a sacral pressure ulcer in early December 2016. A specialist mattress designed to relieve pressure to vulnerable areas was found to be accidentally deflated on 12/12/16. This caused a significant worsening in the condition of the wound. An attempt was made to admit Mrs Robinson into St Austell community hospital on 16/12/16 but this failed due to the wrong form of conveyance being organised. Mrs Robinson was admitted, in a septic condition, into Treliske hospital on 19/12/16. Despite further treatment, she deteriorated and died in the hospital on 21/12/16. 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 will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: Mrs Robinson was using a nimbus 3 air mattress and a Toto (electronic turning device) at the time the mattress was found to be accidentally deflated. The mattress became deflated when the power cable into the pump was dislodged. | understand there was no alarm fitted to the system or any other warning to alert Mrs Robinson to the developing problem. | understand that you are the director with responsibility for the equipment loan service in Cornwall. | do not know whether this was an isolated incident or part of a bigger concern but given the significant contribution the failure of the device had in terms of its contribution to Mrs Robinson’s death, | felt it appropriate to bring the incident to your attention. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you [AND/OR your organisation] have the power to take such action. You will be aware whether this incident may properly be regarded as a “one-off or, alternatively, this is a product where there is an ongoing concern that similar deaths may arise in the future unless action is taken. It would seem to be a relatively simple matter to install an alarm or other warning to a user that a particular mattress is becoming deflated. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 1/8/19. 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 | have sent a copy of my report to the Chief Coroner and to the family of Mrs Robinson. | have also sent it to the MHRA who may find it useful or of interest. | am also under a duty to send the Chief Coroner a copy of your response. 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. [DATE] [SIGNED BY C NER] 03.06.2019 a —_
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.
Information Classification: CONTROLLED 25 September 2019 Mr Andrew Cox Acting Senior Coroner Cornwall and Isles of Scilly The New Lodge Newquay Road Penmount Truro TR4 9AA Dear Mr Cox Re: Regulation 28 Report to Prevent Future Deaths Re: Jeanette Ann Robinson, Deceased Please find below a response from Cornwall Council to the Regulation 28 Report issued on the 3rd June 2019. A schedule of maintenance is in place for all equipment provided by the Community Equipment Loan Store. Additionally, users of the equipment are provided with training and documentation signed by carers is kept within their electronic records held by the Council. Our records show the equipment provided was in service and fully functioning. The Nimbus system is fitted with an alarm that is audible, but can be silenced, as well as a visual alarm on the pump in the event of mains power failure. We have undertaken a process of all Nimbus systems in the community being replaced. This action was taken following clinical reasoning and a new mattress system called Elite is now being used. These are also fully alarmed. Since Mrs Robinson’s death, all Nimbus stock has been destroyed as it was considered defunct. However, the previous service records indicate that there is no evidence to suggest that alarm failure was an issue on the Nimbus system. I trust this provides you with the necessary response to your Section 28 letter. Please do not hesitate to contact me if you require any further information. Cornwall Council | Konsel Kernow New County Hall, Treyew Road, Truro, Cornwall, TR1 3AY T: 0300 1234 100 www.cornwall.gov.uk Information Classification: CONTROLLED Yours sincerely Strategic Director, Adult Social Care & Health Adult Social Care Tel: 01726 226927 Email: h
we Medicines & Healthcare products Regulatory Agency Mr Andrew J Cox, Medicines and Healthcare products Acting Senior Coroner, Regulatory Agency Cornwall & the Isles of Scilly, 10 South Colonnade The New Lodge, Canty Wharf indon Newquay Road, E14 4PU Penmount, Truro United Kingdom TR4 9AA +44 (0) 20 3080 6000 gov.uk/mhra 15 July 2019 Dear Mr Cox, Your ref: AJC/LJB, MHRA Ref: 2019/006/028/601/004 Regulation 28 Report concerning Jeanette Ann Robinson Thank you for your letter of 3 June 2019 in which you asked the MHRA to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Jeanette Ann Robinson. You wanted to know whether this incident may properly be regarded as a "one-off or, alternatively, if this is a product where there is an ongoing concern that similar deaths may arise in the future unless action is taken. You stated it would seem to be a relatively simple matter to install an alarm or other warning to a user that a particular mattress is becoming deflated. Mattresses are medical devices which must be CE marked before they are placed on the market in the UK and throughout the EU. MHRA’s expectation is that, when CE marking and placing a medical device on the market, manufacturers will have evaluated the potential risks that could occur. The CE mark demonstrates that the medical device is fit for its stated intended purpose and meets legislation relating to safety. This requires the manufacturer to demonstrate their medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. Additionally, higher risk medical devices (including these types of mattresses) require certification from a third party conformity assessment body (‘Notified Body”) located in the EU prior to being placed on the market. MHRA is responsible for the oversight of UK Notified Bodies and has a post-market role in investigating reported safety issues via a voluntary reporting system for users (Yellow Card) and a mandatory reporting system for manufacturers. MHRA were unaware of this adverse incident as it was not reported to us by the Royal Cornwall hospital or other third party. Arjo Huntleigh, the manufacturer of the Nimbus 3 alternating pressure mattress, was also unaware of the incident as it was not recorded within their post market surveillance system. Arjo Huntleigh has since logged this event on their system and will present MHRA with their conclusion, although without a serial number to identify the mattress, their report may be inconclusive. Arjo Huntleigh’s initial findings were that Nimbus 3 mattress was on loan from the Adult Social Care service of Cornwall Council, who had no record of problems associated with it, prior to its removal from service and subsequent destruction. The Nimbus 3 alternating pressure mattress pump includes audible and visual alarms for mains power failure, low or high pressure and pump fault conditions. The mains power failure alarm is powered by a rechargeable battery and the instructions for use advise that this function is tested before the system is put into use, as the battery may be flat if the mattress hasn’t been in regular use. The instructions also convey the battery test sequence to be followed. There are no similar adverse incidents involving the Nimbus 3 alternating pressure mattress on MHRA’s adverse incident database, so it is reasonable to assume that there is not a systemic failure with this mattress and there is no further action that MHRA can take. As it has not been possible to investigate the specific mattress involved, we cannot be certain how the failure was caused. | hope the above information is useful. Yours sincerely, co Dr lan Hudson Chief Executive Medicines and Healthcare products Regulatory Agency Telephone: 020 3080 6100
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