The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning multi-function defibrillation electrodes manufactured by Heart Sync Inc. All lots of the following catalogue numbers are affected:
The manufacturer notified customers of a voluntary urgent device correction for certain multi-function defibrillation electrodes due to a connector compatibility issue with Philips automated external defibrillators (AED) models FR3 and FRx defibrillator units. These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the incompatibility issue until the AED must be used. This may result in a delay in electrical therapy, which can lead to death or serious adverse consequences. The manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain AED units.
Philips FR3 and FRx AED units should only be used with the electrodes specified in the equipment manuals.
For details, please refer to the following link:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm425605.htm
http://www.fda.gov/Safety/Recalls/ucm425536.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 December 2014