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Heart Sync Inc. Issues a Voluntary Device Correction for Multi-function Defibrillation Electrodes
FOR IMMEDIATE RELEASE — November 26, 2014 — Detroit, MI Heart Sync Inc. announces that it has 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.
Heart Sync has not received any complaints or Medwatch reports of injuries associated with this Voluntary Device Correction to date.
The affected multi-function electrodes were distributed globally to distributors and medical facilities from October 26, 2011 through November 26, 2014.
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. There are a total of 113,750 electrodes affected by this voluntary device correction. No product needs to be returned to Heart Sync.
All lot numbers of the following Heart Sync electrodes are affected:
- Catalog Number C100-PHILIPS - Adult Radiotransparent Electrode
- Catalog Number C100AC-PHILIPS - Adult Radiotransparent Electrode
- Catalog Number T100LO-PHILIPS - Adult Radiotransparent Electrode
- Catalog Number T100-PHILIPS Radiotranslucent Electrode
- Catalog Number T100AC-PHILIPS Radiotranslucent Electrode
Philips FR3 and FRx AED units should only be used with the electrodes specified in the equipment manuals.
For further information or to report a problem, please contact Heart Sync at 734-213-5530, 24 hours a day, 7 days a week, or email at Jahana@heartsync.net.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.