October 14, 2014 — Covidien has announced a voluntary recall after discovering an electrode connector compatibility issue that may have contributed to a patient’s death.
The problem affects some Medi-Trace Cadence and Kendall defibrillation electrodes, which might not connect with a Phillips FR3 or FRx AED defibrillator. This which could delay treatment for a patient.
Covidien said the FRx AED unit chirps an alarm to warn users when the device is connected to an incompatible electrode. Unfortunately, the Phillips FR3 does not have an alarm, which means the problem may not be discovered until the AED fails during a life-threatening emergency.
According to the recall:
“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.”
Products affected by the recall:
- 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
The recall affects nearly 645,000 electrodes, including some that were sold by Covidien under private-label agreements with MediChoice and Philips HeartStart brand AEDs. In December 2013, the FDA issued a Safety Communication to warn that over 700,000 of the Philips HeartStart FRx AED might have a defective electrical component that could cause the AED to fail to deliver an appropriate shock.