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Mismatched Defibrillator Electrodes Spark Three Major Recalls

Philips FR3 AED
The Philips HeartStart FR3 AED, as shown in a promotional photo on the company's website.

Updated Dec. 29, 2014

There have now been three serious recalls in the United States this year related to 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 three Class I-level recalls.

On December 24, the FDA announced that Heart Sync Inc's Voluntary Urgent Device Correction involving 113,750 Multi-function Defibrillation Electrodes was serious enough to be designated as a Class I-level recall. Ann Arbor, MI-based Heart Sync has been in the process of revising labeling to clarify that the electrodes, distributed between October 26, 2011 and November 26, 2014, are incompatible with the Philips AEDs. (More information is on the FDA's website.

Three weeks before, there was another Class I designation involving 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.)

Both Heart Sync and CONMED said they had 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.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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