2015

PFD Reports
Reports: 477 Areas: 69

62% response rate (below 63% average).

Response Status
Responded 295 Historic 181
AI Classification
Action Taken 47%
Action Planned 30%
Noted 21%
Disputed 2%
Based on 385 classified responses
Top Categories
Hospital Death (Clinical Procedure… (224) Other related deaths (54) Community health care and emergenc… (46) Road (Highways Safety) related dea… (38) Child Death (from 2015) (35)
477 results
Dean Elie
All Responded
2015-0001 6 Jan 2015 London (North)
Department of Health and Social Care
Concerns summary (AI summary) The report highlights a need for consideration of further legislation to address a critical point, indicating a gap in existing legal frameworks relevant to preventing future deaths.
Noted (AI summary) The Department of Health acknowledges the concerns about ensuring patients with capacity attend medication reviews, but states there are no plans to extend mental health legislation and refers to the Mental Capacity Act for those lacking capacity.
James Fyfe
All Responded
2015-0099 5 Jan 2015 Berkshire
Anetic Aid Limited Medicines and Healthcare Products Regul… Royal Berkshire Hospital Trust
Concerns summary (AI summary) The cot side on a trolley could remain in an unlocked position due to design and maintenance issues, which were not clearly highlighted. The MHRA failed to escalate this known hazard to other hospital trusts.
Disputed (AI summary) MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA 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. AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will continue to provide training and support to the hospital staff. Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. 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.