October 14, 2014 — Covidien is recalling Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes because they may not work with Philips FR3 and FRx defibrillators.
The FRx AED unit requires the pads to be pre-connected. If they are not connected, it will issue a continuous chirping alarm to alert the user of the problem. The FR3, however, does not require pre-connection and it does not issue an alarm. Users may not discover the issue until the AED fails to deliver a shock in a life-threatening medical emergency.
The compatibility issue could result in a delay in therapy, which may have contributed to the death of a patient:
“Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.”
The recall affects nearly 645,000 electrodes. Some were sold by Covidien under private-label agreements with MediChoice and Philips HeartStart AEDs.
This is not the first recall affecting the Philips HeartStart. Last year, the FDA issued a Safety Communication and warned that the HeartStart FRx may have a defective electrical component that could cause it to fail to deliver a shock.
Recalled products include:
- 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
- MC1710H – MediChoice® Multifunction Electrode
- M3718A – Philips HEARTSTART Multifunction Electrode Pads
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