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 UK – Service and Technical Centre

ArjoHuntleigh House, Houghton Hall Business Park, St Catherine Street, Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom Gloucester, GL1 2SL, United Kingdom Sales Phone: +44 (0) 1582 745700 Phone: +44 (0) 8456 114114 Sales Fax: +44 (0) 1582 745745 Service Fax: +44 (0) 1452 525207 Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 Email: ukservice@arjohuntleigh.com Rental Fax: +44 (0) 1582 745843 Email: sales.admin@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 UK – Service and Technical Centre

ArjoHuntleigh House, Houghton Hall Business Park, St Catherine Street, Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom Gloucester, GL1 2SL, United Kingdom Sales Phone: +44 (0) 1582 745700 Phone: +44 (0) 8456 114114 Sales Fax: +44 (0) 1582 745745 Service Fax: +44 (0) 1452 525207 Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 Email: ukservice@arjohuntleigh.com Rental Fax: +44 (0) 1582 745843 Email: sales.admin@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 UK – Service and Technical Centre

ArjoHuntleigh House, Houghton Hall Business Park, St Catherine Street, Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom Gloucester, GL1 2SL, United Kingdom Sales Phone: +44 (0) 1582 745700 Phone: +44 (0) 8456 114114 Sales Fax: +44 (0) 1582 745745 Service Fax: +44 (0) 1452 525207 Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 Email: ukservice@arjohuntleigh.com Rental Fax: +44 (0) 1582 745843 Email: sales.admin@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 UK – Service and Technical Centre

ArjoHuntleigh House, Houghton Hall Business Park, St Catherine Street, Houghton Regis, Bedfordshire, LU5 5XF, United Kingdom Gloucester, GL1 2SL, United Kingdom Sales Phone: +44 (0) 1582 745700 Phone: +44 (0) 8456 114114 Sales Fax: +44 (0) 1582 745745 Service Fax: +44 (0) 1452 525207 Rental 24hr Helpline Lo-call Phone: +44 (0) 8457 342000 Email: ukservice@arjohuntleigh.com Rental Fax: +44 (0) 1582 745843 Email: sales.admin@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.

Dear Mr Clark,

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 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 ) Patient Safety NHS Improvement Skipton House, Area 6C 80 London Road SE1 6LH

Friday 1st April 2016

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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.

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 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.

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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

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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