The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning defibrillation electrodes (PN-9131-001) used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E automatic external defibrillators (AEDs) manufactured by Cardiac Science. The affected lot number is 141125-02 and the expiration date of the electrodes is 12 June 2017.
The manufacturer has determined Powerheart G3 defibrillation electrodes (PN 9131-001) from lot number 141125-02 may exhibit higher than expected electrical impedance over time. If electrode impedance becomes too high, the Powerheart G3 AED will fail the electrode self-test performed by the AED and it will not be Rescue Ready. Specifically, if the AED fails the electrode self-test, the STATUS INDICATOR on the AED will be RED and the AED will beep. This is standard behaviour when the impedance limit is exceeded. In order to return the AED to its RescueReady state, the high impedance electrodes require replacement.
The manufacturer advises users to examine the electrodes currently installed in their AEDs and in their inventory. Also, users should replace affected electrodes even if they are in an AED and the Status Indicator is GREEN.
Product replacement is on-going.
For details, please refer to the MHRA website:
https://mhra.filecamp.com/public/file/2c5i-olg1li3l
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 December 2015