The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning PadPro and R2 Multi-function Defibrillation Electrodes manufactured by CONMED. All lots of the following catalogue numbers are affected:
The manufacturer notified customers of a voluntary urgent device correction for certain PadPro and R2 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 therapy. The manufacturer is modifying the labeling to clarify that use of the affected electrodes are incompatible with certain AED units.
For details, please refer to the following link:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424952.htm
http://www.fda.gov/Safety/Recalls/ucm424871.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 November 2014