Pharmaceutical

Defibrillator maker issues Field Safety Alert after incident reports, patient death

defibrillator 435x348 Defibrillator maker issues Field Safety Alert after incident reports, patient deathMedical device maker Covidien has issued a Field Safety Alert for a defibrillator, involving connector compatability issues involving some types of electrodes with certain automatic external defibrillators (AED). The issue involves Medi-Trace Cadence and Kenall Multi-function Defibrillation Electrodes when used with Phillips FR3 and FRx Defibrillators.

Covidien has received two reports where customers attempted to use a Covidien electrode with a Phillips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the death of another patient.

AEDs are portable electronic devices used to treat life-threatening cardiac dysrhythmias, ventricular fibrillation and pulseless ventricular tachycardia. Defibrillation consists of delivering a therapeutic dose of electrical energy to the heart.

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 Sept. 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.

Covidien is recommending that Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual.

Any quality problems or adverse events related to these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

About 45,000 reports of AED failures have been submitted to the FDA since 2006. This prompted the agency last year to propose new guidelines that would require manufacturers of both new and existing devices to provide clinical data or other evidence that proves their defibrillators are safe and effective. Defibrillator makers would also be required to provide inspection reports and inform the FDA if there are any changes to the devices.

Sources:
FDA
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