Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0103, written 23 Mar 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 23 Mar 2015 |
|---|---|
| Reference | 2015-0103 |
| Deceased | Joseph Allison |
| Coroner | Ian Wade QC |
| Coroner area | East London |
| Category | Product 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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. 2. , Director, Handicare Accessibility Ltd., 82 First Avenue, Pensnett Estate, Kingswinford, West Midlands, DY6 7FJ Director-General, British Healthcare Trades Association, New Loom House, Suite 4.06, 101 Back Church Lane, London E1 1LU 1 CORONER I am Ian Wade QC, assistant coroner, for the coroner area of London East 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 31st October 2013 I commenced an investigation into the death of Joseph Allison, 84, born 10th October 1928. The investigation concluded at the end of the inquest on 11th March 2015. The conclusion of the inquest was that Mr Allison died from 1a. Bronchopneumonia; 1b. Fracture dislocation of cervical vertebrae; 2. Chronic bronchitis and emphysema, and a narrative conclusion was returned as follows: “Mr. Joseph Allison had a mechanical stairlift known as a Minivator 2000 installed in his home. It was serviced annually. It contained components which were subjected to stress forces during the course of usage and which were at risk of physical failure due to a design fault. These components had been the object of a manufacturer's upgrade programme between 2004 and 2006 but which had not been applied to this stairlift. These stairlifts were in addition the specific object of engineering bulletins but these were not applied to this stairlift. On the 18th October 2013 the upper trunnion assembly broke up while Mr Allison was operating the lift at the top of the staircase and he was precipitated down the stairs causing inter alia a fracture in the cervical vertebrae and a trauma injury to the head leading to intracerebral bleeding. These injuries substantially compromised his ability to resist the impact of respiratory infection leading to Bronchopneumonia from which he died on 27th October 2013”. 4 CIRCUMSTANCES OF THE DEATH (1) Mr Allison was thrown from a stairlift in his home when components in the upper trunnion assembly failed. (2) The components were manufactured from inadequate materials and it was also acknowledged by the manufacturer in 2004 to be a faulty design. The manufacturer’s upgrade programme was not properly or sufficiently carried out with the result that Mr Allison’s stairlift was not given the retro-fitted parts which would have avoided this incident. (3) Moreover the manufacturer’s internal record of compliance progress was 1 completed so as falsely to show that the necessary work had been carried out. (4) In addition an engineering bulletin known as Bulletin 55 was issued to give guidance to fitters on the work required to upgrade this stairlift, and a subsequent Bulletin 66 was issued to instruct fitters on how to check a stairlift in situ in order to assess whether the critical component was in a safe condition, but service engineers were not given training, equipment nor specific reminders/alerts to investigate such stairlifts during routine maintenance visits. (5) Furthermore no information regarding this defect and the necessary remedial actions was released to appropriate third parties such as independent stairlift installers or dealers. (6) A total of 21 Minivator 2000 stairlifts have suffered the relevant component failure since this lift was first manufactured, 11 of which have occurred since the purported upgrade programme was terminated. 16 stairlifts were discovered to have been falsely recorded as upgraded following a recent audit, although these have since been correctly improved. However the manufacturer admits that 567 units have not been tracked down and rectified, and efforts to locate them have so far failed. (7) The further circumstances in the instant case are illustrated in the terms of the narrative conclusion. 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 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. – (1) In-house service engineers have not been specifically trained to be aware of the defect in the Minivator 2000, nor issued with feeler gauges to implement the appropriate safety check (2) In-house and third party service engineers are thereby exposed to the same risks which end-users face if they test-ride the serviced stairlifts themselves (3) No nationally publicised safety recall campaign has been undertaken to alert end-users to the danger, or request that such users contact the manufacturer for access to the remedial programme (4) No or no adequate initiative has been taken to advise the stairlift industry generally of the risks inherent in unimproved Minivator 2000 stairlifts 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you and 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 Monday 18th May 2015. 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, . I 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 2 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 Monday 23rd March 2015 [SIGNED BY CORONER] 3
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.
lan Wade QC
Assistant Coroner
Eastern District of London
Walthamstow Coroners Court
Queens Road
Walthamstow
London E17 8QP 15 May 2015
Dear Mr Wade
Re: Inquest touching upon the death of Joseph AuW Son
Thank you for drawing our attention to your investigation and conclusions with regard to the
above case.
To address your points:
1 and 2 - we are satisfied that Handicare has adjusted internal process and training to
ensure that appropriate training is provided to the in-house engineers on an ongoing
basis. BHTA will remind all its manufacturer members that if training is necessary to
address a field safety issue the training must continue to be provided until such time as all
the products have been traced and the necessary action taken.
3 BHTA has been concerned for some time that there is no national alerting system for
notification of product recalls and field safety work for products such as stairlifts. We have
noted that is currently leading a review into the recall system for unsafe
products to which we will be responding:
https://Awww.gov.uk/ overnment/news/consumer-
product-safety-review
Clearly there is a need for a national system, but we are also conscious that costs and
effectiveness might be barriers. There is a well-established system run by the Medicines &
Healthcare Products Regulatory Agency (MHRA) for alerts regarding medical devices and
this ensures wide circulation throughout the health and care sectors. We will recommend
that the Health & Safety Executive talk to the MHRA and see if they might tap into the same
alerting system for alerts regarding products which are not medical devices but which have
been sold into the care sector, provided to social services, or sold direct to frail elderly
people for the purpose of maintaining independence, preventing falls, and / or enabling
champion-lynn-faulds-wood-to-lead-
mobility.
= New Loom House - Suite 4.06
101 Back Church Lane
London - E1 1LU
? x ,
continued overleaf... bi
British Email: bhta@bhta.com
—_—_ Heathcare
co Kasoeeton “APPROVED coDe Wwww.bhta.com
British Healthcare Trades Association
A company limited by guarantee
? England No. 164121
At the heart of heattheare since 4{7 fara gino
apr
4 The business did raise the matter at one of our meetings (minutes of which are distributed
to all relevant members) and we have discussed how to improve notifications and co-
operation throughout the supply chain. We will reiterate to manufacturers the need to have
written agreement with their dealers setting out what will be expected of them in the event of
a recall or the need for field safety work; and that they should make full use of ourselves and
the publications read by businesses in the sector to raise awareness.
If we may be of any further assistance please do not hesitate to contact me.
Yours sincerely
Director General
& handicare Handicare 82 First Avenue Pensnett Estate Kingswinford West Midlands DY6 7FJ Me len Wale QC United Kingdom Assistant Coroner Eastern District of London a i” Walthamstow Coroner’s Court F Queens Road enquiries@handicare.co.uk Walthamstow www.handicare.co.uk London E17 8QP 12” June 2015 - fo) : Dear Sir Re: Inquest touching upon the death of Mr Joseph Allison We write further to your Regulation 28 Report to prevent future deaths sent under cover of your letter of 25th March 2015 and subsequent exchanges of correspondence regarding an extension of time in which to submit a response. This letter constitutes the response to your Regulation 28 Report. Before addressing the section of your Report which deals with "Matters of Concern" it is felt appropriate to deal with two matters which arise out of our consideration of the section headed "Circumstances of Death" which we feel, as currently worded, may have the capacity to mislead Someone reading the Report who did not have the benefit of the full background or having heard all of the evidence given at the Inquest. The first matter relates to Paragraph 4(3) where it is respectfully submitted that the use of the following phrase has the potential to mislead: "Moreover the manufacturer's internal record of compliance was completed so as to falsely show that the necessary work had been carried out."' Our concern is that the word "falsely" in the context of the sentence as constructed has the capacity to be interpreted in a way which suggested some deliberate act or act of dishonesty on the part of the company was involved in the factual narrative. Plainly that is not the case, was not the evidence given in writing or orally at the Inquest, and no witness was questioned on the basis that such could have been the case, as should have been done, really, if such a matter was to be in question. In our view the sentence would be more reflective of the actuality and the evidence given were it to read "Moreover the records compiled by the manufacturer to capture Mobility Stairlifts, Moving & Handling The second matter relates to the sentence appearing at paragraph 4(5) which reads: “Furthermore no information regarding this defect and remedial actions was released to appropriate third parties such as independent installer or dealers.” Again, in our view, and respectfully, we say that this is capable of being misleading. As was clear from the evidence submitted in writing and the evidence given orally at the Inquest Bulletins 55 and 66 were mailed to our trade customers at the time of issue. This would include independent installers and dealers, and, in fact, as was explained, all those to whom we knew the business had supplied a stairlift or who were regularly maintaining stairlifts. What was not done at the time, and what we understood the concern to be directed to during the course of the Inquest, was to distribute such information to other independent installers and maintainers, outside of the group reached, in order to cover the potential scenario whereby a stairlift had been sold or installed second- hand outside the knowledge of the business or was being serviced by someone outside our known and identifiable network of installers, dealers, and maintainers. In our respectful view the sentence would more reflective of the evidence if it read "Furthermore whilst efforts were made to provide information on the defect and remedial actions to those to whom the manufacturer had supplied stairlifts or it knew maintained stairlifts such information was not supplied to others who might have sold or installed stairlifts second-hand or who were maintaining stairlifts outside the manufacturers identifiable network of businesses which maintain stairlifts." We will now address the matters set out in the section of your report entitled "Matters of Concern". “5(1) In-house service engineers have not been specifically trained to be aware of the defect in the Minivator 2000, nor issued with feeler gauges to implement the appropriate safety check.” Action Taken Handicare engineers have been made aware of the potential defect, issued with feeler gauges and have received a face to face briefing with regard to its use to carry outa trunnion inspection as detailed in Bulletin 66. The content of Bulletin 66 has also been issued to them. They have also been issued with a list of recall batch serial numbers. Training with the feeler gauge anda briefing on the top trunnion issue has been added to the new engineer training programme together with a list of the recall batch serial numbers, to ensure that any new employees are made aware of the issue as part of their induction training. It will be recalled that Bulletin 66, which formed Appendix B to the statement of Mr explained what needed to be done to identify the defect and what action should be taken immediately if a defect was found. “5(2) In-house and third party service engineers are thereby exposed to the same risks which end users face if they test ride serviced stairlifts themselves” Action Taken In relation to in-house service engineers please see the response to paragraph 5(1) above. We are contacting all dealers that have ordered stairlifts or spares since 2005 to raise awareness of the defect and upgrade programme. We are issuing the recall batch numbers with the request to contact us if they come across any of these units in the field. We have also purchased a list of UK mobility retailers and are sending a similar communication to any of these dealers not already registered with us and covered by the communication referred to in the Paragraph immediately above. First class mailing of these communications took place 11” and 12” June 2015. A communication covering similar ground will also be included as an insert, for ease of extraction and retention, in THIIS (stands for "The Homecare Industry Information Service") magazine, the primary trade publication. This is planned for the July issue of this monthly magazine. We attach examples of the communications which are being sent to our dealer network, are being sent to the list of dealers who are not part of our established dealer network, and are to be inserted into THIIS magazine marked as TM1, TM2 and TMS respectively. “5(3) No nationally publicised safety recall campaign has been undertaken to alert end users to the danger, or request that such users contact the manufacturer for access to the remedial programme.” Action Taken We will be conducting a national advertising campaign in the Publications identified to us by external specialists as having the highest readership and best national coverage. This will run between Monday 15" June and Sunday 4" July. Adverts will run on various days in the following publications: The Sun (National), The Scottish Sun, the Daily Mail and the Mail on Sunday. We are also mailing all Local Authorities to raise awareness of this recall in case they have had an affected stairlift installed by a third party. First class mailing of these communications took place 11" and 12" June 2015. We attach examples of the adverts which are to appear in the national newspapers and the communications to be sent to local authorities marked TM4, TM5 and TM6 respectively. The Group function is also in the Process of reviewing the viability of incorporating a section on the Handicare website, to be accessible by any visitor to the website, listing safety upgrades, including the Minivator 2000 trunnion upgrade. This site is managed by Handicare Group’s central marketing department not a local UK team and serves a number of divisions so changes like this go through a consultation process. As matters stand we cannot confirm whether or not this is something for which we will get authority to proceed. “5(4) No adequate initiative has been taken to advise the stairlift industry generally of the risks inherent in unimproved Minivator 2000 Stairlifts.” Action Taken In relation to the generality of the concern expressed please see the responses/action taken in relation to paragraphs 5(2) and 5(3) above. As regards the topic of all manufacturers or all leading manufacturers sharing information on such issues within the sector generally, from our recollection, this was tabled by our representative at a meeting of the stairlift section of the BHTA once the original trunnion upgrade programme was initiated, to highlight the need to share safety information between companies. At the time some manufacturing members of the section were opposed to creating a formal system due to concerns about the requirement to share data or information which may be commercially confidential or commercially sensitive in its nature, and therefore this was rejected. We have raised the matter informally with the BHTA again, both before and following the Inquest. There is a BHTA stairlift section meeting planned for the 9" July 2015, the first such meeting following the Inquest, where this will be tabled once more for consideration. We will raise the issue again with all manufacturers at this meeting to try to highlight the importance of sharing such information in order to reduce the risks to users of stairlifts with potential safety issues. A letter will also be sent to these manufacturers during the week commencing 15” June 2015, We believe we have done all that we can to address the concerns identified in the Regulation 28 Report. As will no doubt be readily understood the safety of users of our products and of our staff who maintain them is of the utmost importance to us and that is why we always seek to review our processes to identify areas for risk reduction and improved accident prevention. We are, therefore, appreciative of your drawing our attention to the matters highlighted in the Regulation 28 Report. At the risk of repeating what has already been said Publicly at the Inquest we must reiterate how deeply saddened we were at the circumstances of the accident involving Mr Allison following what was thought to have been a successful initial upgrade programme. If there is anything further with which we can help, or if any clarification is required, please get in touch. Yours faithfull Sales & Marketing Director For and on behalf of Handicare Accessibility Ltd Encs: TM1 to TM6
See every Prevention of Future Deaths report matching Product related deaths, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.