A Field Safety Alert was issued for some of Covidien’s defibrillator electrodes. According to the alert, certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes will not connect with Philips FR3 and FRx Defibrillators. There are at least two reported incidents “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.”
An automated external defibrillator (AED) is a portable device that attempts to correct a life-threatening heart rhythm using electrical shocks. The alert states that the Philips FR3 and FRx AED units are not compatible with certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes; trying to pair these AEDs with the electrodes will delay therapy that can save a patient’s life. The FRx AED requires the pads to be connected before use, so a continuous chirp alarm will notify the user that the appropriate pads are not connected before the device is used. The FR3, on the other hand, does not require the pads to be connected beforehand; therefore, the users will not realize that the electrodes are incompatible until the unit needs to be used, causing a delay in therapy.
Customers were notified of the issue in a letter dated September 18, 2014. The labeling has been modified to reflect the incompatibility issues. The alert affects a total of 644,460 electrode, which, according to the Covidien press release, 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
The alert urges customers to only use FR3 and FRx AED units with the appropriate Philips brand electrodes specified in the equipment manual. Customers should also ensure that compatibility issues do not occur in the future by checking to see that Covidien electrodes are not placed with Philips model FR3 or FRx AEDs.