UPDATED 12/24/2014. Recall classified as Class I.
AUDIENCE: Risk Manager, Consumer, Emergency Medicine, Biomedical Engineering
ISSUE: Heart Sync Inc. notified customers of a Voluntary Urgent Device Correction for certain 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 may not discover the incompatibility issue until the AED must be used. This may result in a delay in electrical therapy, which can lead to death or serious adverse consequences.
BACKGROUND: The affected multi-function electrodes were distributed globally to distributors and medical facilities from October 26, 2011 through November 26, 2014. There are a total of 113,750 electrodes affected by this voluntary device correction. Refer to the press release for a list of affected electrodes.
RECOMMENDATION: No product needs to be returned to Heart Sync. Heart Sync alerted customers to this issue by letter on November 11, 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
[12/24/2014-Recall Notice- FDA]
[12/03/2014 - Press Release - Heart Sync Inc.]
[12/03/2014 - Product Labels - FDA]