The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom posted a field safety notice concerning HeartStart FRx, HeartStart Home, and HeartStart OnSite automated external defibrillators (AEDs), manufactured by Philips.
The manufacturer has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 AEDs that were manufactured between 2002-2013.
According to the manufacturer, virtually all of these resistor-related failures were detected through the device's automatic self-testing, alerting the user by issuing audible chirps. The in-use reliability of these AEDs is greater than 99.9% when the AED determines a cardiac arrest victim is in need of shock therapy.
In the extremely rare circumstances, the automated tests fail to detect the AED's inability to function normally, and fail to deliver a shock when one is needed, putting patients at risk of not receiving adequate therapy for their VF or VT, potentially resulting in serious injury, or even death.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-5-to-9-march-2018
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 March 2018