Incident report on monitoring alarm failure

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.

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).

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.