Covidien has notified customers of a voluntary Field Safety Alert for some lots of Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes because of a connector compatibility issue with Philips FR3 and FRx defibrillators.
The Covidien electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could delay resuscitation. With the FRx AED defibrillator, the pads need to be pre-connected, and the unit will issue a continuous alarm chirp if the proper pads are not connected prior to use. The FR3 does not require pre-connection and so the user will not discover the compatibility issue until the AED must be used. This may delay defibrillation, the company said in its press release.
Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The incompatibility of the devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.
The Food and Drug Administration (FDA) has classified this as a Class 1 recall, the most serious recall category, where there is a reasonable risk of a serious adverse health consequences or death.
The alert advises customers to review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.
A total of 644,460 electrodes are affected by this safety alert. These affected electrodes are:
22660R Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent
22660PC Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect
20660 Kendall Adult Multi-Function Defibrillation Electrodes
40000006 – Kendall 1710H Multi-Function Defibrillation Electrodes
These private label electrodes produced by Covidien have the same connector compatibility issue:
MC1710H MediChoice Multifunction Electrode
M3718A Philips HEARTSTART Multifunction Electrode Pads