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 the Recall
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