Aftermarket Philips FRx / FR3 Defib Pads - 2 Major Recalls
Two serious recalls have now taken place in the United States this year amid confusion over which electrodes to use on certain Philips automated external defibrillators.
The Dutch multinational made changes to the connector design of its FR3 and FRx AEDs, according to the FDA. But health providers and other users apparently did not understand that the changes meant that the Philips AEDs should ONLY be used with the Philips brand electrodes specified in equipment manuals.
Hundreds of thousands of other electrodes are now part of two Class I-level recalls.
The FDA this week issued a Class I designation for Utica, NY–based CONMED Corp.’s recall of 174,610 PadPro and R2 Multi-function Defibrillation Electrodes distributed from March 1, 2012 through October 29, 2014, with CONMED alerting customers that the electrodes no longer work with the AEDs. (More information is on the FDA’s website.)
CONMED said it has not received any reports of deaths or injuries. But that was not the case for Covidien and its similar recall in October of more than 600,000 Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes, as well as Covidien-produced private label electrodes including some MediChoice Multifunction Electrodes and Philips Heartstart Multifunction Electrode Pads.
Covidien had two reports of a mismatch that delayed resuscitation. One of the cases may have contributed to a death, according to the company. (More information is on the FDA’s website.)
Philips had a fail-safe with the FRx AED units, which require pre-connection of pads and continuously issue an alarm chirp if incompatible pads are used. The FR3, though, does not require pre-connection, and the user will not discover the compatibility issue until the AED is used.