James Fyfe

Peter J Bedford 
Senior Coroner for Berkshire 
Yeomanry House 
131 Castle Hill 
Reading 
Berkshire 
RG1 7TA 

AneticAid 

I The Theatre Equipment Specialists 

Our Ref: 

Date: 2nd  February 2015 

Dear Mr Bedford, 

Re: JAMES WILSON FYFE decd REGULATION 28 REPORT 

With reference to the regulation 28: report to prevent future deaths (1) received on 5 th  January 2015, please find 
below our comments as requested in relation to the areas for concern in section (1) of paragraph five. 

Design 

The QA3 trolley was designed to the relevant standards (including but not limited to BS 5402, BS EN 60601-1 
and the relevant particular standards of the BS EN 60601-2 range), leading up to its launch in 1998. 

•

•

•

The side rail (cotside) is counterbalanced so that positive force is required by the end user to fully lower 
it and this also assists the end user whilst raising it, before it locks into place. This is a specific design 
feature to ensure that the side rail does not descend in an uncontrolled manner; as we had determined 
this to be an unacceptable risk. 

Tolerance variations in components, materials, finishes and workmanship — along with wear and tear - 
may result in variations in performance, but do not affect the locking mechanism. 

The 11,680 QA3's produced to date have an exceptional safety record after 17 years in use, with a 
conservative estimate of 65,000,000 side rail operations having taken place. 

Naturally following the incident at Royal Berkshire Hospital, we have been rigorously examining our design 
criteria and our user safety records. Based on extensive post market surveillance, we find the design has a 100% 
safety record in its primary role of retaining the side rail in a raised position when locked — irrespective of levels of 
maintenance, or variations in performance. 

This post market surveillance also indicates positive feedback in regards to the QA3's usability: its primary 
functions being simple and intuitive. We believe that incorporating additional safety features would have 
unintended consequences: adversely effecting usability, create additional unacceptable risks, and will not make 
the mechanism immune from user error. 

It should also be noted that the QA3 side rail is not unique in its locking mechanism and the risks associated with 
side rails are well known (refer to the attached issued in 2004) — therefore the issue is proved to be not solely 
linked to this device. 

Maintenance 

Our maintenance schedules are a basic guideline for clients who wish to know what our engineers are inspecting 
during scheduled service visits by Anetic Aid. They act as a reminder to both parties of the steps to be followed 
during on-site visits. The full criteria for work carried out during a scheduled maintenance visit — including the side 
rail mechanism - is part of our on-going training regime for our engineers. 

While Anetic Aid annually services 3,700 QA3 trolleys, to date, no feedback has been received — either from end 
users, or from our engineers - to suggest the performance of the QA3 side rail should be subject to review for 
retrospective field action. 

SPECIAIJSING Dir 

Patient S. Surgery Trolley Systems 

Operation Table Accessories 

Stainless Steel Theatre Furniture 

Surgical Instruments 

•

Electro•Surgical Accessories ' 

. Tourniquet Systems 

Fibre Optic Instruments 

Service & Maintenance 

Anetic Aid Ltd. 
Queensway, Guiseley, Leeds, 
West Yorkshire, LS20 9JE, UK. 

T 01943 878647 
F  01943 870455 

salesganeticald.corn 
www aneticald.com  

Directors! Guy Schofield, Andrew Curtin, Alex Clark [Company Secretary), 

Anetic Aid Ltd. is part of the Portsmouth Surgical Holdings Grout) 

Registered offices: Anetic Aid Ltd., Queenswav, Gulseley. Leeds,  West Yorkshire, LS20 9JE. UK. 

Company registered in England & Wales No 1331679 

VAT Reg. No 301 2589 92 

 
 AneticAid 

The Theatre Equipment Specialists 

The incident involved in Mr Fyfe's death remains the only reported incident of this nature and Royal Berkshire 
Hospital is the only known site where an issue with the side rail performance has been raised as a concern. 

We would therefore suggest that the design of the QA3 side rails, their performance and our methods of 
maintaining them, do not require retrospective change to prevent future deaths, but that our actions should be 
focused specifically on supporting Royal Berkshire Hospital. 

As has been recognised, we have commenced with a programme of QA3 end user training with Royal Berkshire 
Hospital staff, and this has been on-going since the incident. We will actively continue to support this. Through 
our communication with the Hospital, we understand a program of safety notices and reminders to staff; 
highlighting the careful use of side rail, has been undertaken. We would suggest this to be an effective way of 
addressing what we perceive to be a localised issue. 

Yours sincerely 

Technical Controller 

SPECIALISING fit 

Patient P. Surgery Trolley Systems 

Operation Table Accesiones 

Stainless Steel Theatre PurnnLire 

Surgical Instruments 

ErectraSsinpiabrAcc.esSoPes (cid:9)

- 

Tourniquet Systems 

Fibre Optic Instruments 

Service & Maintenance 

Anetic Aid Ltd. 
Queensway, Guiseley, Leeds, 
West Yorkshire, LS20 9JE, UK. 

T 01943 878647 
F  01943 870455 

salesganeticaid.com  
www.anetcaid.com  

Directors Guy Schofield, Andrew Curtin, Alex Clark (Company Secretary( 

Anetic Aid I.Td Is part of the Portsmouth Surgical Holdings Group 

Registered offices Anetic Ald Ltd , Queensway. Gulseley. Leeds, West Yorkshire, LS20 9JE, UK 

Company registered in England & Wales No 1331679 

VAT Reg. No • 301 2589 92

( Medicines and Healthcare 

Products Regulatory Agency 
• • • 

151 Buckingham Palace Road 
London SW1W 9SZ 
United Kingdom 

mhra.gov.uk  

Mr Peter J Bedford 
Senior Coroner for Berkshire 
Yeomanry House 
131 Castle Hill 
Reading 
RG1 7TA 

Your ref: 

My ref: 

27/02/2015 

Dear Mr Bedford 

Regulation 28 Report: JAMES WILSON FYFE decd 

Thank you for your Regulation 28 report which we received on 31 December 2014_ 
Here is my reply to your matters of concern (2): 

The Jury were informed that MHRA were aware of the investigation of the incident trolley but 
that it did not appear that the issue had been escalated and notified to all Hospital Trusts and 
agencies that used this type of trolley. The MI-IRA's actions in being informed of this potential 
hazard remain unclear, with particular reference to passing on the known risk to such trolley 
users. 

Background  
This incident was reported to MHRA by the Royal Berkshire Hospital (RBH), part of the Royal 
Berkshire Foundation Trust, on 29 March 2011, without naming the patient, as is usual for 
patient confidentiality reasons. The Trust did not inform MHRA of the patient's subsequent 
death. The incident was again reported to MHRA in August 2011 by the deceased's son, 
, Senior Medical Device Specialist, 

confirmed with RBH that this was the same incident that they had reported in March 2011. 

The incident details provided by RBH were that a "Patient was admitted to A&E with pain in his 
hip after a fall at home. The patient went for an X-ray and whilst the film was being processed, 
the radiographer heard a noise and found patient on the floor. The patient had a large 
laceration to forehead and various grazes to right arm and right hand. He was seen by a 
doctor, examined and dressing applied to his forehead, arms and hands. The trolley was 
removed from use. Checks by nursing staff found it to be in working order, however it is being 
sent to the Clinical Engineering department for further testing. Clinical Engineering has 
contacted Anetic Aid Ltd who are sending a technician to examine the trolley". 

MHRA asked Anetic Aid Ltd to investigate under the EU medical device Vigilance 
arrangements and to inform us of their findings and of any consequent action they proposed to 

cpRD 

N I BSC 

(cid:9)
 
 
 
 
 
 
 
 _ take, liaising with RBH if they required any further details of the incident. They were informed 
that MHRA had no objection to RBH releasing the trolley involved in the incident for analysis 
as part of their investigation. 

Summary of Anetic Aid Ltd investigation - 2011.  
Anetic Aid Ltd visited RBH on 1 April 2011 to •examine •the trolley. The serial number of the 
trolley was 2139 and it was supplied to RBH in March 2002. Anetic Aid Ltd had no record of its 
maintenance history as at that time there was no service contract between Anetic Aid Ltd and 
RBH. Both side rails were tested by applying weight to each end of the side rail and forcing 
them downwards. This procedure was repeated in the centre of the side rail. The side rail 
remained in their upright, locked positions. At the time of their inspection, both side rails' 
locking mechanisms were workin9 correctly, although they were worn. The manufacturer 
concluded the cause of the incident was user error and not equipment failure. 

MHRA review of incident - 2011.  
Anetic Aid sent MHRA their investigation report on 6 April 2011. 
investigation report and based on this report, agreed the cause of the incident appeared to be 
user error and not equipment failure. The incident was transferred to our surveillance database 
in September 2011. 

 reviewed their 

MHRA did not publish a Medical Device Alert (MDA) concerning the QA3 Patient Trolley. At the 
time of the incident  11,090 QA3 trolleys had been' produced with the same design of locking 
mechanism for the side rails. There were no prior related incidents reported to either MHRA or 
Anetic Aid Ltd for the period the trolley had been placed on the market, 1998 to 2011. 
It is important to note that not all incidents result in the issue of a MDA. MHRA received 10,984 
incident reports (relating to 21,729 incidents) in 2011 and issued 114 MDAs. There would be 
a real risk of diluting the impact and importance of alerts if the system were to be used to 
distribute large numbers of alerts. In addition, Government agencies are trying to reduce the 
burden on the NHS and are working with fewer resources themselves. 

MHRA only publish a MDA when it has been identified through our internal governance 
systems that additional measures are needed to deliver important device safety messages to 
healthcare providers and users. The decision to publish a MDA is based on a full 
consideration of an assessment of the risks associated with the adverse incident involved. 

MHRA review of incident - 2015 
The current version of the QA3 trolley uses the same type of locking mechanism and it is 
essentially unchanged, having the same characteristics. Anetic Aid Ltd state that QA3 sales 
now total 11,680 units. Since the incident in 2011 there have been no further reports to MHRA 
or to the manufacturer of any users other than RBH experiencing problems with the side rails 
not locking when they are raised. RBH sent us reports in March 2013 and November 2014 
which were added to the surveillance database, each detailing one failure. 

MHRA were informed by Anetic Aid Ltd that the QA3 trolleys in use within the RBH were 
placed under a maintenance agreement with Anetic Aid Ltd. from May 2011 and periodic 
service visits were carried out, together with user training, as and when identified as being 
required. RBH and Anetic Aid Ltd appear to have worked together to produce a maintenance 
checklist for RBH's QA3 trolleys: we are not aware that Anetic Aid Ltd have taken this measure 
with any other hospital as these problems have not occurred elsewhere. 

Mr Marsden visited RBH on 14 January 2015 to examine some examples of their QA3 trolleys 
that they felt had safety issues with the side rails. Whilst there was evidence of some 
components being defective, such as damping springs, and a variance in the force needed to 
raise the side rails was apparent, the locking mechanisms seen on all examples were fully 
functional and, following the instructions for use, were intuitive to use. 

Mr Marsden also visited the manufacturing site of the Anetic Aid Ltd QA3 trolley, Portsmouth 
Surgical Equipment Ltd, on 2 February 2015. The two companies are related. The purpose of 
the visit was to discuss the design aspects of the locking mechanism. The design of the 0A3 

 was seen to have changed very little in terms of its mechanisms and functions since its 
inception. The instructions for use, valid at the time of the incident, were deemed to be 
sufficient for safe use of the side rails, following provision of user training. This is specified in 
their Quality System (PROC-160) and includes reference to the latest instructions for use. 
Training is usually provided by either a Regional Account Manager or a Sales Director and the 
manufacturer keeps a record of the training certificates they have issued. However, it appears 
that RBH had not received any training from the manufacturer before the incident occurred. 

Anetic Aid Ltd revised the instructions for use for the latest model of QA3 in March 2013. The 
addendum below was added to the section concerning the operation of the side rails. The 
manufacturer did not issue a Field Safety Notice, as the revision was considered to be part of 
the process of continuous product improvernent.They did not send the revised instructions for 
use to existing 'customers, only to new customers. 

WARNING: After raising the side rail, it is important to ensure that it has locked in position by 
pushing down on the side rail; failure to ensure the side rail is properly locked could result in 
injury to the patient. 

discussed the QA3 instructions for use with the manufacturer in consideration of 
your Regulation 28 report, advising the manufacturer to review them again to ensure that they 
are still accurate and appropriate. 

 additionally contacted four other Hospital Trusts via our Medical Device Safety 

Officer (MDSO) network, each of which have over one hundred QA3 trolleys in use, to 
establish whether they have had this problem but had not reported it to MHRA. The three 
Trusts that replied indicated that they had not experienced this problem, again suggesting that 
it is a local issue within RBH. 

Summary 
MHRA does not normally require manufacturers to modify medical devices or instructions for 
use on the basis of a single report or a single report source, unless it is clear from the report 
that the device did not function as intended. Enough evidence needs to be gathered in the 
form of further reports or other evidence before it can be argued that the device is not 
functioning as intended. It is important for reporters to continue to report further adverse 
incidents when they happen, rather than assuming that nothing will come of these reports. 
When enough evidence is submitted, MHRA will act within the measures of the law. It is 
through these systems, coupled with joint partnership working with the NHS that MHRA can 
help to protect the safety of medical devices users. 

MHRA believes RBH should continue to work with the manufacturer to address any 
shortcomings in user training regarding the safe use of the QA3 trolley. 

MHRA will remind Anetic Aid Ltd to follow their Quality System and ensure all customers are 
offered training in the use of these trolleys. 

I hope this information gives you the assurance that we have acted both appropriately and 
within our remit. 

Yours sincerely, 

Director of Devices 
Telephone: 
E-mail:

Royal Berkshire 
NHS Foundation Trust 

Executive Offices 
Royal Berkshire Hospital 
Level 4, Main Entrance 
London Road 
Reading 
Berkshire 
RG1 5AN 

Tel: 0118 322 7230 
.wwwroyalberkshire.nhs.uk 

PRIVATE AND CONFIDENTIAL 

Mr Peter J Bedford 
HM Coroner for Berkshire 
Yeomanry House 
DX: 40124 
Reading Castle Street 

27 February 2015. 

Dear Mr Bedford 

Re: Regulation 28 Response on the matter of James Fyfe ("JF") (Deceased) 

The Trust has investigated and acted upon your concerns as set out in your Coroner's 
Regulation 28 Report to prevent future deaths dated 5 January 2015. 

Our understanding of your concerns that require action by the Royal Berkshire NHS 
Foundation Trust  ("Trust")  are: 

1. Assurance is required that the Trust has introduced improved service sheets for the 

trolley. 

2. Assurance is required that the Trust has involved Anetic Aid Limited  ("AA")  in maintaining 

and repairing the trolley. 

• 

3. Employee training in the use of the trolley. 

4. A problem has been highlighted with maintenance schedules for the trolley. 

Response 

The Trust response to the concerns expressed by you is as follows: 

1. The Trust has contracted with AA to undertake periodic inspection and as required 
maintenance on all of its QA3 trolleys. AA engineers provide the Trust with a 
'maintenance entry sheet' during every inspection/maintenance visit to the Trust detailing 
the trolleys inspected, the faults identified and the actions taken to remedy those faults. 

2. The Trust has further updated its Clinical Engineering Checklist for AA QA3 trolleys to 
expressly -  detail the checks that  must  be undertaken during every inspection of a QA3 
trolley. 

 
 
 
 
 
 Royal Berkshire 
NHS  Foundation Trust 

After the incident the Trust instigated  a  "Remember 'Clunk - Click' every trip" 
campaign across the Trust. The  campaign included placing a 'Clunk — Click' screen 
saver on Trust computers, placing campaign posters strategically across the Trust and 
ensuring updated user instructions were added to the Trust's training website. This 
campaign was re-instigated across the Trust in January 2015. 

4. Responsibility for developing QA3 trolley maintenance schedule lies with AA as the 
trolley manufacturer and following the Inquest into JF's death, the Trust entered into 
correspondence with AA with a view to AA amending its servicing schedule for QA3 
trolleys. 

On  2nd  February 2015, AA informed the Trust in an email that it was not prepared to 
incorporate the Trust's recommendations on the inspection of QA3 trolley cot sides into its 
servicing schedule. AA advised the Trust that the reason for it taking this position is due 
to AA not wishing to "set a precedent that we would be uncomfortable with". 

At the conclusion of the Inquest into JF's death, the Trust entered into discussions with 
the Medicines and Healthcare Products Regulatory Agency  ("MHRA"),  which sets the 
standards for the management of medical devices, including trolleys. The MHRA is in 
discussions with AA to resolve the servicing schedule issue. 

However, as an interim measure, the Trust insists that AA inspects and maintains its QA3 
trolleys in accordance with its Clinical Engineering Checklist, which the Trust believes, in 
practice, deals with your fourth concern under the R.28 Report. 

In summary, the Trust believes that it has . taken all appropriate steps to address all of your 
concerns under R28. While no permanent solution has been found to the fourth concern 
expressed under Regulation 28, this matter is outside the Trust's control. 

If you have any queries regarding the Trust's response please contact 
on 

Yours sincerely 

Jean O'Callaghan 
CEO