Eileen Thompson

David Clark, 
Assistant Coroner, 
Warwickshire Justice Centre, 
Newbold Terrace, 
Leamington Spa, 
Warwickshire. 
CV32 4EL 

April 5th, 2016 

SUBJECT: 

Regulation 28 Report – Eileen Annie Thompson 

Dear Sir, 

  Firstly please let us state that we were very sorry to hear of the passing away of the lady 
involved in this incident and wish to pass our condolences onto the family.  ArjoHuntleigh 
received your letter, via email, in regard to the above case on the 3rd March 2016.  

ArjoHuntleigh utilises a global vigilance system for its distributed devices and as part of this Post 
Market Surveillance (PMS) system we have investigated this unfortunate incident and reviewed 
the recommendations from the inquest and would like to respond as documented below: 

  We have enquired with the supplier of the bed in question and it has been confirmed that all 4 
brakes on the bed were working to specification. As the supplier had not been informed of the 
incident the actual bed in question had been out on loan another 4 times since the original 
incident.  

  We have recreated a simulation of the incident in a laboratory environment and are able to 
conclude the following: 

·  It is possible to apply all four brakes on the bed castors, even when the bed is placed 

alongside a wall/s. After setting the bed in its intended position, it is still possible to 
access to the brakes that are next to the wall/s. 
One wall 

ArjoHuntleigh UK – Head Office 
ArjoHuntleigh House, Houghton Hall Business Park, 
Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom 
Sales Phone: +44 (0) 1582 745700 
Sales Fax: +44 (0) 1582 745745 
Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 
Rental Fax: +44 (0) 1582 745843 
Email: sales.admin@arjohuntleigh.com 

www.arjohuntleigh.co.uk 

ArjoHuntleigh UK – Service and Technical Centre 
St Catherine Street, 
Gloucester, GL1 2SL, United Kingdom 
Phone: +44 (0) 8456 114114 
Service Fax: +44 (0) 1452 525207 
Email: ukservice@arjohuntleigh.com 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Two walls 

·  The Instruction For Use (#746-396-UK rev.6 dated on February 2010) provides all 

necessary information regarding usage of the brakes. It also warns the user about 
necessity of applying all 4 brakes to prevent the bed from moving whilst in use with a 
patient.    

ArjoHuntleigh UK – Head Office 
ArjoHuntleigh House, Houghton Hall Business Park, 
Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom 
Sales Phone: +44 (0) 1582 745700 
Sales Fax: +44 (0) 1582 745745 
Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 
Rental Fax: +44 (0) 1582 745843 
Email: sales.admin@arjohuntleigh.com 

www.arjohuntleigh.co.uk 

ArjoHuntleigh UK – Service and Technical Centre 
St Catherine Street, 
Gloucester, GL1 2SL, United Kingdom 
Phone: +44 (0) 8456 114114 
Service Fax: +44 (0) 1452 525207 
Email: ukservice@arjohuntleigh.com 

 
 
 
 
 
 
 
 
 
           
 
 
 ·  The lowest height level that the bed can be set to is approximately 28 cm. During the 
incident the bed was in use with a mattress (unknown what type). According to the 
Instruction For Use for the Minuet 2, it can be used with a mattress of maximum height 
12,5 cm. Therefore the maximum height from which the patient could have fallen is 
established to be approximately 40 cm. Moreover, the IFU warns the user that the bed 
should be lowered to the minimum height position whenever the patient is left 
unattended. 

·  The force needed to move the bed from the wall is strictly correlated with an actual load 
applied on the bed and coefficient of the friction between castors and floor. With the 
limited information provided, we were unable to recreate the same conditions as during 
the event occurrence, but we did manage to perform a test to estimate the force needed 
to push the bed from the wall while an 80 kg person is lying on the bed, whilst the bed 
was situated on a hard and smooth surface offering low friction and resistance to castor 
movement. During the test, it was concluded that a relatively big force (450N) is needed 
to push the bed away from the wall and this activity was described as ‘hard’ by the 
person involved in the test. 

·  The Minuet 2 bed device can be used with safety side panels, which act as a mechanical 

barrier for the patient to reduce the possibility of unintentional exit from the bed. They are 
however not intended to restrain patients who make a deliberate attempt to leave the 
bed. Please note that this is an optional function proposed for this bed and the decision 
whether to use it or not should be made by a qualified personnel. 

·  As per the Instruction For Use provided for this particular bed (#746-396-UK rev.6 dated 
on February 2010) a clinically qualified person responsible is to consider the size, age 
and condition of the patient before allowing the use of safety sides.  

ArjoHuntleigh UK – Head Office 
ArjoHuntleigh House, Houghton Hall Business Park, 
Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom 
Sales Phone: +44 (0) 1582 745700 
Sales Fax: +44 (0) 1582 745745 
Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 
Rental Fax: +44 (0) 1582 745843 
Email: sales.admin@arjohuntleigh.com 

www.arjohuntleigh.co.uk 

ArjoHuntleigh UK – Service and Technical Centre 
St Catherine Street, 
Gloucester, GL1 2SL, United Kingdom 
Phone: +44 (0) 8456 114114 
Service Fax: +44 (0) 1452 525207 
Email: ukservice@arjohuntleigh.com 

 
 
 
 
 
 
 
 
 Extract from IFU 

We should also like to point out that we were informed of the incident on the 15th February 2016, 
which is approximately 6 weeks after the incident occurred and 3 days after the conclusion of the 
coroner’s inquest. 

We believe that our original risk assessment (as detailed in our product risk management files 
DHF 2400-304.2_4 HTM Minuet 2) adequately addresses the hazardous situation identified. 
Based on the performed investigation, it seems that the patient was assessed as being 
unsuitable for safety side use due to her condition. Additionally, the user placed the bed in the 
lowest position and with mattresses on the floor. Putting the bed in lowest position is not an 
uncommon practice but placing mattresses on the floor is not considered normal clinical practice. 
It appears to indicate either the expectation from the user that the person would attempt to leave 
the bed intentionally or at minimum that there were circumstances relating to the use of the bed 
that were not shared with the manufacturer.  

ArjoHuntleigh UK – Head Office 
ArjoHuntleigh House, Houghton Hall Business Park, 
Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom 
Sales Phone: +44 (0) 1582 745700 
Sales Fax: +44 (0) 1582 745745 
Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 
Rental Fax: +44 (0) 1582 745843 
Email: sales.admin@arjohuntleigh.com 

www.arjohuntleigh.co.uk 

ArjoHuntleigh UK – Service and Technical Centre 
St Catherine Street, 
Gloucester, GL1 2SL, United Kingdom 
Phone: +44 (0) 8456 114114 
Service Fax: +44 (0) 1452 525207 
Email: ukservice@arjohuntleigh.com 

 
 
 
                   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 In conclusion we believe that the root cause for this event is related to the combination of the use 
of the device and the patients' health state (including pre-existing conditions). Taking into the 
consideration that the patient, who was involved in this particular event, was diagnosed with 
dementia and had no upper body stability, it seems unlikely that a gap between the wall and bed 
frame could have been created in an immediate manner, without a significant effort from the 
patient side. We have reviewed the current warnings included with our products, which we feel 
are clear and fit for purpose and have also undertaken PMS reviews to highlight similar incidents 
globally (none) and therefore feel that no further action is required in this matter. 

Yours Sincerely 

Andy Ellis 
Director Quality & Regulatory Compliance – North Europe 

On behalf of  
ArjoHuntleigh 

cc: AHVigilance, UKSSUComplaintHandling 

ArjoHuntleigh UK – Head Office 
ArjoHuntleigh House, Houghton Hall Business Park, 
Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom 
Sales Phone: +44 (0) 1582 745700 
Sales Fax: +44 (0) 1582 745745 
Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 
Rental Fax: +44 (0) 1582 745843 
Email: sales.admin@arjohuntleigh.com 

www.arjohuntleigh.co.uk 

ArjoHuntleigh UK – Service and Technical Centre 
St Catherine Street, 
Gloucester, GL1 2SL, United Kingdom 
Phone: +44 (0) 8456 114114 
Service Fax: +44 (0) 1452 525207 
Email: ukservice@arjohuntleigh.com

Mr David Clark 
Assistant Coroner 
Warwickshire Justice Centre 
Newbold Terrace 
Leamington Spa 
Warwickshire 
CV32 4EL 

(Sent by email to: wa-
warwksmcenq@hmcts.gsi.gov.
uk ) 

Dear Mr Clark, 

Patient Safety 
NHS Improvement 
Skipton House, Area 6C 
80 London Road 
SE1 6LH 
https://www.improvement.nhs.uk  

                        Friday 1st April 2016 

Regulation 28 Report to Prevent Future Deaths following the inquest of Eileen 

Annie Thompson who died on 29 December 2015.  

I am writing to you to respond to the concerns raised by your investigation into the 

circumstances surrounding the tragic death of Eileen Annie Thompson.  

NHS England’s patient safety team regularly reviews serious incidents reported to 

the National Reporting and Learning System (NRLS) and other sources of data to 

learn from errors that have occurred in the NHS. When appropriate, we issue Patient 

Safety Alerts to warn the healthcare system of new risks and to provide guidance on 

preventing potential incidents that may lead to patient harm or death. Our different 

types of Alerts (Warning, Resource and Directive Alerts) are issued via the Central 

Alerting System (CAS) to NHS Trusts in England and others, who have asked for 

notification (e.g. independent providers of health and social care). It may be helpful 

to note that the Patient Safety Team will move from NHS England to NHS 

Improvement on 1st April 2016. 

From your report we understand that the incident, which led to the accidental death 

of Eileen Annie Thompson, involved a bed, which has been designed for use in 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 residential settings for people with mobility problems or those who need nursing 

care. In this case, the locking mechanism for the inner wheels was not easily 

accessible because the bed was placed against a wall.  

The two inner wheels were not locked and as a result, the bed moved from the wall. 

You raised concerns that there is risk of recurrence in respect of service users who 

are provided with this type of bed when the bed is placed against a wall and asked 

us to take action, which should include an explanation of the steps we have taken to 

raise awareness of the risk and to issue appropriate instructions regarding the 

locking of wheels. 

Following receiving your report we have explored the risk and identified the following 

issues: 

Although some beds for use in residential settings are available, which have a 

central locking mechanism (e.g. all wheels are locked by locking one of the pedals), 

it seems that most beds are similar to the Minuet bed, which has four individually 

lockable wheels. We therefore feel that the risk does not only apply to a particular 

brand, but will relate to a wide range of beds used in residential settings.  

We have reviewed some randomly selected user manuals and found that the level of 

information provided varies and is often not clear. For example: 

  Some instructions for use (IFUs) state that wheels have to be locked in certain 

situations, e.g. during construction, when nursing or positioning a patient, 

before the user is moving in or out of bed. We feel that IFUs should include 

the advice that wheels should always be kept locked and only be released if 

the bed needs to be moved.  

  No specific information about brakes has been found if the bed is positioned 

against a wall. The only advice found is that the pedal/ handle for operating 

the bed should be on the accessible side if the bed is positioned against a 

wall.  

2 

 
 
 
 
 
 
   A particular IFU advises that the bed should be positioned at an appropriate 

distance from walls. The reason for this was to prevent damage or patient 

injury when operating the bed; the accessibility of brakes or the risk of the bed 

moving has not been mentioned.  

  Some examples suggest that locking two out of the four wheels is efficient 

(e.g. at least one castor at the head end and one castor in the foot end must 

be locked.). We feel that this is helpful and adequate advice because the 

locking mechanism provides lengthwise and crosswise locking and will 

therefore hold the bed in position.  

Good clear instructions for use have a crucial role in the safe and effective use of 

device. The manufacturer is responsible for supplying appropriate instructions, taking 

into account the knowledge and training of the intended user(s). Any shortcomings in 

the instructions should be reported to the Medicines and Healthcare product 

Regulatory Agency (MHRA) as an adverse incident. It is within the remit of the 

MHRA to investigate such reported incidents and to ensure that user instructions are 

clear. 

Our planned action: 

We will discuss the risk and our findings with the MHRA as we feel that it is within 

their remit to improve the advice provided in user instructions. We will highlight the 

fact that some IFUs do not seem to provide enough guidance for staff and that 

advice is needed on how to safely use a bed with individual wheels, if it is positioned 

against a wall. Advice is also required on how many wheels need to be locked to 

hold the bed in position.   

You may consider sending the Regulation 28 Report to the MHRA so they can 

respond directly about the actions they are planning to take to prevent similar 

incidents in the future. If the company which supplied the bed is currently 

investigating the incident, the MHRA will probably be already aware of this case.  

3 

 
 
 
 
 
 
 
 Further issues identified: 

In domestic situations it is not always possible to apply the same standards as in a 

clinical environment.  Spaces can be small and client/patient preferences are being 

taken into account. Therefore, it is not unusual for beds in residential homes and 

private residences to be placed against a wall.  

The difficulty of locking wheels is not new to many staff as often the brake at the top 

end of the bed cannot be locked if the bed is positioned in the corner of a room. We 

are aware that that the risk of beds moving is covered in some local staff training 

programmes to raise awareness.  

Qualified nurses and occupational therapists are often responsible for assessing and 

prescription of beds. They usually complete a risk assessment, which includes e.g.  

  Patient factors (risk of falling and if any equipment such as bedrails are 

required to minimise the risk) 

  Equipment factors (suitability, benefits and risks of particular equipment) 

  Environmental factors (assessing space for the bed/ for safe patient care and 

transfer).  

We understand that practices vary greatly; for example, different local providers 

undertake risk assessments in different ways, and local equipment suppliers provide 

different services. 

There is currently no nationally agreed standardised home visit framework.  

We feel that staff is aware of the problem but that the solution is not always straight 

forward. We therefore think that new resources are required for staff to assess the 

risks more carefully and to be able to make adequate decisions with regards to the 

safe use of beds.  

Our proposed action: 

We will work with the College of Occupational Therapists and other stakeholders to 

drive the development of new national resources.  Opportunity will be taken to 

ensure that these incorporate and build upon existent national guidance on falls 

prevention and the safe use of bedrails. Once new resources have become 

4 

 
 
 
 
 
 available, we will explore the option of issuing a stage 2 alert to signpost to the new 

resources. We feel that this proposal will be more effective in preventing further 

incidents than just raising awareness by issuing a warning alert to staff. 

We would be happy to keep you informed of our process and we are very grateful to 

you for bringing your findings from your investigation of Mrs Thomson’s death to our 

attention. 

Please accept my best wishes, 

NHS National Director of Patient Safety 

NHS Improvement 

Cc:  

, MHRA Director of medical devices 

, Professional Advisor for Older People and Long Term Conditions at 

the College of Occupational Therapists 

5