Covidien (NYSE:COV) issued a field safety alert on some of its Medi-Trace Cadence and Kendall defibrillation electrodes, saying a connector compatibility issue with defibrillators made by Philips (NYSE:PHG) may have contributed to the death of a patient.
The electrodes in question will not connect with Philips FR3 or FRx AED defibrillators and can result in a delay of therapy, according to a press release. Covidien said it received 2 reports in which customers attempted to use a Covidien electrode with a Philips FR3 AED unit, with the mismatch contributing to "a delay in resuscitation" that "may have contributed to the subsequent death of 1 patient."
The company said the FRx AED unit chirps an alarm to warn users when the device is connected to an incompatible electrode. But the Philips FR3 does not sound an alarm, meaning the problem could go undetected until the AED is needed in a life-threatening situation, according to the release.
The FDA said Covidien alerted customers with a Sept. 18 letter and has revised the labeling on the electrodes to reflect the potential connection problem with the Philips devices.
Nearly 645,000 electrodes are affected by the alert, including electrodes produced by Covidien for distribution under private-label agreements for the MediChoice and Philips HeartStart brands.