UPDATED 12/02/2014. FDA has classified this as a Class I recall.
AUDIENCE: Risk Manager, Consumer, Emergency Medicine, Biomedical Engineering
ISSUE: CONMED Corporation notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the incompatibility issue until the AED must be used. This may result in a delay in therapy.
BACKGROUND: The affected multi-function electrodes were distributed globally to distributors and medical facilities from March 1, 2012 through October 29, 2014. Refer to the press release for a list of affected adult and pediatric electrodes.
RECOMMENDATION: No product needs to be returned to CONMED. CONMED alerted customers to this issue by letter on November 6, 2014 and is in the process of revising its labeling to clarify the use of these electrodes as incompatible with the Philips FR3 and FRx AED units.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178