Conmed Corporation of Utica, New York, issued a Voluntary Urgent Device Correction for certain adult and pediatric PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units.
These electrodes will not connect with Philips FR3 or FRx automated external defibrillator (AED) units. 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 incompatibility issue until the AED must be used. This may result in a delay in therapy.
The affected multi-function electrodes were distributed globally to distributors and medical facilities from March 1, 2012, through October 29, 2014. There are a total of 174,610 electrodes affected by this voluntary device correction.
Conmed is in the process of revising its labeling to clarify the use of these electrodes as incompatible with the Philips FR3 and FRx AED units.
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, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues