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Electrode Incompatability

Electrode Incompatability

Please be aware and use caution when purchasing electrodes for your AED. Covidien brand electrodes are not compatible with Philips FR3 and FRx AED defibrillators. Philip FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual. 

 

For more information, please see the news release below or go to the link here:

 

 

Published in Medical Law Perspectives

Covidien issued 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 AED Defibrillators.

An automated external defibrillator (AED) is a portable electronic device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat them through defibrillation, the application of electrical therapy that stops the arrhythmia, allowing the heart to reestablish an effective rhythm. Uncorrected, these cardiac conditions (ventricular tachycardia, ventricular fibrillation, asystole) rapidly lead to irreversible brain damage and death, once cardiac arrest takes place. After approximately three to five minutes in cardiac arrest, irreversible brain/tissue damage may begin to occur.

Covidien received two reports by customers who 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. Covidien alerted customers to 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.

The Medi-Trace Cadence and Kendall 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. Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual.

The Field Safety Alert applies to all lot numbers distributed globally. There are a total of 644,460 electrodes affected by this safety alert. The following Covidien electrodes are affected:

22660R – Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent

22660PC - Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect

20660 - Kendall™ Adult Multi-Function Defibrillation Electrodes

40000006 - Kendall™ 1710H Multi-Function Defibrillation Electrodes

In addition, similar private label electrodes produced by Covidien were also distributed under the following brands, and have the same connector compatibility issue:

MC1710H - MediChoice Multifunction Electrode

M3718A – Philips HEARTSTART Multifunction Electrode Pads

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

See theRecall

See also Medical Law Perspectives, November 2013 Report:Diagnosis and Treatment of Heart Attacks: Liability Issues

See also Medical Law Perspectives, February 2013 Report:Emergency Medical Services: Liability and Immunity for Medical Rescue

 

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