Faulty Bed
16. Mrs L told us she was trying to extend the bed to make her legs more comfortable. She told us she heard a ping and the foot board ‘sprang up’, took her arm upwards which caused her to fall to the floor. She said the foot board landed on her which fractured her left hip. Mrs L told us a witness in the bed opposite claimed to have seen something ‘ping’ off the bed.
17. The Trust has said the bed was not faulty. It says Mrs L fell whilst adjusting the bed and pressed a lever which made the foot board come off, as it is designed to do in emergency situations. It apologised for the distress and pain Mrs L went through.
18. We have seen in the records from 19 January 2024 nursing staff recommended Mrs L for one hourly visual checks due to her risk of falling. The risk assessment noted Mrs L was occasionally unsteady on her feet and had a history of falls.
19. In Mrs L’s medical records, we can see staff recorded the incident as an unwitnessed fall around 11.40am on 21 January. The falls assessment says staff attended after Mrs L screamed in pain. The clinical notes and incident report say Mrs L had fallen on her left side on top of the foot board and needed a HoverJack (an inflatable lifting device) to get her back into the hospital bed.
20. The Trust’s policy for the management of reusable medical devices (which includes beds) states staff are responsible for ensuring any medical device is fit for purpose, and if there are any concerns they should seek advice from the team which maintains the device. If it is unclear who maintains the device, staff should contact the clinical engineering team. The Trust has told us the medical device safety team (MDST) are responsible for reviewing the medical device when staff record an incident involving a medical device. The policy also states any medical device involved in an incident must be removed from service.
21. The records show staff did not consider the incident to be related to the bed. The Trust told us staff reattached the foot board and did not report the bed as faulty because they had no reason to believe it was faulty. Therefore, staff did not record the serial number of the bed on the incident report. We consider the Trust’s investigation into this incident later in the report.
22. As staff did not record the incident as involving a medical device, the Trust did not pass on the incident to the MDST or the clinical engineering team to assess whether there was any fault with the bed. The Trust told us the bed has now been moved and is no longer traceable because the serial number was not recorded.
23. It is not possible to say, even on the balance of probabilities, whether the bed was faulty and caused Mrs L to fall. This is because the bed was not documented or reviewed by the proper maintenance teams, leading to a lack of evidence for us to consider to help us weigh up the accounts of what happened. We appreciate this may be disappointing to those involved and that is not to say we disbelieve either Mrs L or the team who cared for her.
24. We understand the lack of a concrete answer on this point may also be distressing to Mrs L.
Physiotherapy support
25. Mrs L told us she could not remember being offered physiotherapy whilst in the hospital and certainly had not received any since she was discharged. Mrs L told us she still experiences pain in her leg since the incident.
26. The Trust told us after the incident on 21 January, staff referred Mrs L to the physiotherapy team on 22 January. It says the team reviewed her on 24 January, 26 January, 30 January, 31 January, and 2 February. It said the physiotherapy team discharged Mrs L on 2 February.
27. The records show times when Mrs L was in too much pain or too tired for physiotherapy. The records also document instances of physiotherapists and ward staff helping Mrs L to get out of bed and walk short distances with a Zimmer frame.
28. The Trust also told us staff arranged an occupational therapy referral. Occupational therapy then arranged home equipment and a care package which included four daily visits. It also said staff made a referral to the Integrated Care Team – Therapy (ICTT), which is part of another trust, which does not form part of this complaint. It said this referral was for ongoing community physiotherapy and occupational therapy support.
29. Mrs L’s medical records support the Trust’s explanation. There is clear documentation of Mrs L engaging with the physiotherapy team on these dates, and a referral sent to the community therapy service on 2 February.
30. Section 8 of the Quality Assurance Standards for Physiotherapy outlines how physiotherapists should gather and analyse the best available information to formulate a treatment plan, identify appropriate treatment options, and arrange a discharge or transfer of care on completion of the treatment plan.
31. To conclude, Mrs Mallison had regular physiotherapy support when she was an inpatient at the Trust with the aim of returning her mobility to what it was before the fall and a referral onwards for community care.
32. We hope this information reassures Mrs L she received physiotherapy whilst in hospital, and the Trust referred her to a community service for further support in line with the Quality Assurance Standards for Physiotherapy.
Incident investigation – bed investigation
33. Mrs L has told us she believes the Trust did not properly investigate the incident or her concerns about the safety of the bed and did not take witness statements from her or another woman who saw the incident. She says the lack of clarity and investigation has meant she is terrified a similar incident will happen to someone else.
34. The Trust told us it appropriately investigated the incident as a fall, based on the view Mrs L fell when adjusting the bed. It told us there is no requirement to gather witness statements from other patients in fall investigations.
35. We reviewed the Trust’s incident investigation records. This included the original incident report (21 January 2024), a falls root cause analysis (25 January 2024) and an inpatient falls review (4 April 2024) alongside Mrs L’s clinical records.
36. The Trust’s incident management policy says all incidents and near misses must be reported on the local incident and risk management system immediately or at the earliest opportunity. The clinical notes state the system was down at the time of the incident, and staff completed the incident report an hour later when they were able to access the system.
37. MHRA guidance defines a medical device as a healthcare product or piece of equipment a person uses for a medical purpose. The Public Access Registration Database for MHRA registered medical devices shows the bed used (an Arjo Enterprise hospital bed) is an officially registered medical device.
38. The Trust policy for the management of reusable medical devices states staff should record any incident involving a medical device and report this to the MHRA if the incident meets the criteria. The criteria for reporting an incident to the MHRA includes when someone is injured by a medical device, either because its labelling or instructions are not clear, it is broken, or has been misused.
39. The Trust’s initial incident report did not identify a piece of medical equipment was involved in the incident. The Trust has told us staff were able to reattach the foot board and did not consider it to be faulty at the time. The Trust told us if the staff had identified a fault with the foot board at the time of the incident, they would have put this on the incident form and the medical device safety officer team would then checked the equipment.
40. In the incident investigation report of the incident, we can see a senior nurse noted Mrs L had pressed a lever causing the bed to release, which then led to her fall. The Trust did not include this account in the falls root cause analysis (RCA) and the inpatient falls review meeting (IFRM).
41. Based on the policy and MHRA reporting criteria, if staff considered the foot board came off due to Mrs L adjusting the bed and losing her balance when it came off, they should have still identified this as involving a medical device and reported this, even if they did not consider the bed to be faulty. We find the Trust should have reported the bed was involved in the incident. As this did not happen, we have not seen evidence the Trust appropriately investigated Mrs L’s complaint, and we consider this is a failing.
42. If the Trust had correctly identified the incident (which resulted in injury) involved a medical device, we find it is likely the Trust would have reviewed the bed and investigated for any possible faults. We cannot conclude whether the investigation would have found faults with the bed.
43. The Trust has told us the bed was moved from the ward and it has no record of where it is now because it did not include the serial number in the incident report. This means there is likely no way to find and review the specific bed now.
Incident investigation – patient involvement
44. Neither the incident management policy nor the prevention and management of inpatient falls policy states staff should take witness statements from patients involved in the incident/fall or other patients who witnessed this.
45. The Trust’s actions do not amount to a failing when it did not take witness statements from Mrs L or the patient who claimed to see the incident. This is because there is no policy requirement for staff to do this.
46. The incident management policy outlines the patient safety framework standards which states an effective incident response system prioritises compassionate engagement and involvement of those affected in the incident. The falls management policy does not specifically state the Trust need to include the patient when conducting an RCA or IFRM. Based on these guidelines, we would expect the incident report and investigation to include a record of Mrs L’s views on what caused the incident/fall.
47. We have not seen evidence following the initial incident report on 21 January, that staff recorded or considered Mrs L’s account of the incident until the formal complaint in July. We have only seen a repetition of the view from the initial incident report in the incident investigation, stating Mrs L fell when adjusting the bed. The Trust then used this view as the basis for the RCA and IFRM.
48. If the Trust had asked Mrs L for her views on what happened when reporting and initially investigating the incident, this could have presented further opportunity for the Trust to identify and investigate the bed and provide an answer to Mrs L’s concerns about whether the bed was faulty.
49. Mrs L told us she made an informal verbal complaint in January 2024 to one of the nurses where she first shared concerns about the safety of the bed. From what we have seen in the record, we cannot see evidence of a recorded complaint earlier than 29 July or any staff notes relating to Mrs L’s concerns about the bed. If Mrs L made a verbal complaint to staff in January about the faulty bed, it is likely they did not handover this information as none of the reports or investigation notes state there were any concerns about the bed.
50. The Trust’s final response refers to a conversation Mrs L had with the matron involved in the investigation shortly after receiving a letter in January 2024. The final response states the matron reassured Mrs L over the phone about how the bed frames are designed to come off. This suggests the Trust were aware of Mrs L’s concerns before the outcome of the falls investigation and IFRM.
51. The Trust said staff spoke to Mrs L on the phone a number of times throughout the investigation period. We have not seen any record of these conversations outside of this complaint response. We have also not seen evidence of Mrs L’s voice or concerns in any part of the investigation documentation.
52. Based on the evidence, the Trust did not include Mrs L’s views in the initial incident reporting and investigation. The Trust also did not record or consider later concerns Mrs L shared about the bed or include this in any further investigation into the incident. The Trust’s actions are not in line with the guidelines promoting patient involvement in incident reporting and investigation, and this is a failing.
53. Mrs L has told us she is terrified another incident will happen because the Trust did not properly investigate the bed or listen to her concerns. As the Trust’s actions mean we will never conclude whether the bed was faulty, Mrs L has lost the opportunity to gain a concrete answer. We appreciate she has been concerned and worried since her fall in January 2024, and the Trust responses have failed to remedy her fear.