PFD report

Eileen Annie Thompson · Prevention of Future Deaths report

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Issued 15 Feb 2016•Warwickshire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
2

Raised in this report

Recipients
3

Named on the report

Responses found
2

Of 3 recipients

Stated actions
5

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised2

  1. Inaccessibility of inner-wheel locking mechanisms when beds are placed against walls
    Part of recurring concern: Unreliable stability controls for wheeled furniture in patient-care areas
  2. Failure to lock the inner wheels of beds
    Part of recurring concern: Unreliable stability controls for wheeled furniture in patient-care areas
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Work with occupational therapy and other stakeholders to develop new national resources for assessing and safely using beds.

    Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 15 February 2016.
  2. Action

    Discuss the bed-wheel safety risk and identified guidance gaps with the MHRA.

    Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 15 February 2016.
  3. Action

    Recreate the incident in laboratory testing to assess brake operation, bed positioning, and movement conditions.

    Stated by ArjoHuntleighStated completedThe respondent said that this action was complete when they made their response on 15 February 2016.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    No further action was considered necessary after post-market surveillance identified no similar incidents globally.

    Stated by ArjoHuntleighNo action considered necessaryThe respondent said that no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Inaccessibility of inner-wheel locking mechanisms when beds are placed against walls

Wider context from the report

“(1) The bed was able to move from the wall because the two inner wheels were not locked. (2) The locking mechanism for the inner wheels was not easily accessible when the bed was placed against a wall. (3) 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. ”

Is this part of a recurring concern?

Yes — Unreliable stability controls for wheeled furniture in patient-care areas.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to lock the inner wheels of beds

Wider context from the report

“(1) The bed was able to move from the wall because the two inner wheels were not locked. (2) The locking mechanism for the inner wheels was not easily accessible when the bed was placed against a wall. (3) 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. ”

Is this part of a recurring concern?

Yes — Unreliable stability controls for wheeled furniture in patient-care areas.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Work with occupational therapy and other stakeholders to develop new national resources for assessing and safely using beds.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response2
Page 4 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Discuss the bed-wheel safety risk and identified guidance gaps with the MHRA.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response2
Page 3 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Recreate the incident in laboratory testing to assess brake operation, bed positioning, and movement conditions.

Verbatim wording from the response

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

Source location

E-Thompson-Response
Page 1 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

No further action was considered necessary after post-market surveillance identified no similar incidents globally.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response
Page 5 · response
Published 15 February 2016

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Review current product warnings to assess whether they clearly address the identified hazards and safe bed use.

    Stated by ArjoHuntleighStated completedThe respondent said that this action was complete when they made their response on 15 February 2016.
  2. 2

    Conduct post-market surveillance reviews for globally similar incidents involving the product.

    Stated by ArjoHuntleighStated completedThe respondent said that this action was complete when they made their response on 15 February 2016.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.3

  1. 1

    Manufacturers are responsible for supplying appropriate bed instructions, while MHRA investigates reported shortcomings and ensures instructions are clear.

    Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
  2. 2

    The event’s root cause was attributed to device use and the patient’s health state; creating the wall-bed gap was considered unlikely without significant effort.

    Stated by ArjoHuntleighDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
  3. 3

    The existing product risk assessment and warnings were considered adequate, clear and fit for purpose for the hazardous situation.

    Stated by ArjoHuntleighExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review current product warnings to assess whether they clearly address the identified hazards and safe bed use.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response
Page 5 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct post-market surveillance reviews for globally similar incidents involving the product.

Verbatim wording from the response

“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:”

Source location

E-Thompson-Response
Page 1 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Manufacturers are responsible for supplying appropriate bed instructions, while MHRA investigates reported shortcomings and ensures instructions are clear.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response2
Page 3 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The event’s root cause was attributed to device use and the patient’s health state; creating the wall-bed gap was considered unlikely without significant effort.

Verbatim wording from the response

“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.”

Source location

E-Thompson-Response
Page 5 · response
Published 15 February 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The existing product risk assessment and warnings were considered adequate, clear and fit for purpose for the hazardous situation.

Verbatim wording from the response

“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 performance 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.”

Source location

E-Thompson-Response
Page 4 · response
Published 15 February 2016

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
2/3

Data last updated 7 September 2026