The Australia Therapeutic Goods Administration (TGA) and the Health Canada posted medical device safety alerts concerning Kendall 1010P Multi-Function Defibrillation Electrodes [Model no.:22660PC, 22660R] & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes [Model no.: 40000006] manufactured by Covidien LLC.
According to the medical device safety alerts, there was incompatibility between the Philips Automated External Defibrillators (AED) models FR3 and FRX defibrillators and Covidien Medi-Trace cadence and Kendall Defibrillation Electrodes. These electrodes will not connect with Philips FR3 and FRX AED units, and in the case of the use of Covidien Defibrillation Electrodes with the Philips FR3 AED units, could result in a delay of therapy. 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 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 Health Canada and TGA websites:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/41547r-eng.php
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01034-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Sep 2014