UPDATED 10/21/2014. Recall classified as Class I.
AUDIENCE: Risk Manager
ISSUE: Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.
Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.
BACKGROUND: These electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could result in a delay of therapy. 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 compatibility issue until the AED must be used. This may result in a delay in therapy.
Covidien alerted customers to the this issue by letter on September 18, 2014, and has revised labeling to clarify that use of these electrodes is incompatible with Philips FR3 and FRx AED units. There are a total of 644,460 electrodes affected by this safety alert. See Firm Press Release for electrodes affected including additional brands.
RECOMMENDATION: Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual. Customers should review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.
For further information or to report a problem, please contact Covidien Quality Assurance at 1-800-962-9888, option 8, then extension 2500 between the hours of 8 a.m. and 5 p.m. (eastern) or email Mansfield.firstname.lastname@example.org
Health care providers and consumers may report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:
• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
[10/21/2014 - Recall Notice - FDA]
[10/10/2014 - Firm Press Release - Covidien]