Recommendation R11: Incident report on monitoring alarm failure
From The Allitt Inquiry Report, published 11 February 1994.
Recommendation
We recommend that in the event of failure of an alarm on monitoring equipment, an untoward incident report should be completed and the equipment serviced before it is used again (para 5.11.6).
Government response
Recommendation 11. We recommend that in the event of a failure of an alarm on monitoring equipment, an untoward incident report should be completed and the equipment serviced before it is used again. This recommendation has been considered by the Expert Advisory Working Group appointed by the Medical Devices Agency who have responsibility for the safety and quality of medical devices. The draft recommendations of this Expert Group go further than those of recommendation 11. The Group is expected to present its final report later this month.
Delivery
DHSC and NHS England state no delivery position (27 February 2026)
The principal route for reporting regarding failure of a device to sound an alarm, would be to the MHRA Yellow Card system and the manufacturer. The MHRA yellow card system exists for reporting suspected medical device incidents and defective or falsified products to the MHRA.
Incident data should also be inputted into local risk management systems, such as Datix. As the new national NHS system for the recording and analysis of patient safety events, Learn from Patient Safety Events (LFPSE), supports live data upload from such systems which will then be fed back to the MHRA to investigate. The current overarching framework for the reporting of patient safety incidents is the Patient safety Incident Response Framework (2023).
Site note: DHSC and NHS England's own account of progress, supplied to the Thirlwall Inquiry in September 2024 and printed in the Inquiry legal team's Review of Implementation of Recommendations from Previous Inquiries into Healthcare Issues (version dated April 2025, published 27 February 2026). It is not a finding of the Inquiry. Their reviewed extent of implementation reads “Superseded”. Table row: section 3.2 No. 11, PDF page 19.
What other bodies have found
In their own words. These do not change the delivery statement above.
Thirlwall Inquiry legal team (15 May 2024)
In November 1994, the Secretary of State for Health said this recommendation had been considered by an expert advisory working group which had produced draft proposals which went further than this recommendation.
Site note: The Thirlwall Inquiry legal team's own notes on implementation, from its Review of Implementation of Recommendations from Previous Inquiries into Healthcare Issues (version of 15 May 2024). The review does not colour its Extent of Implementation cell for this recommendation green; it leaves the cell uncoloured where a recommendation was rejected, where evidence of implementation was insufficient, or where steps had been taken but implementation was not yet complete. Table row: section 3.2 No. 11, PDF page 19.
Responsible bodies
Themes and tags
Who has spoken
- Department of Health and Social Care
Response - DHSC and NHS England
Delivery statement - Thirlwall Inquiry legal team
Finding