Philips made changes to the connector design of their FR3 and FRx Automated External Defibrillators (AEDs). Because of these changes, Heart Sync electrodes will no longer work with these AEDs. This is the third company who has recalled their electrodes in relation to their incompatibility with these Philips Automated External Defibrillators. These electrodes will work with other Philips AEDs that accept plug style connectors.
Electrodes are connected to an AED, which analyzes the heart rhythm in cardiac arrest patients and delivers an electrical shock to restore normal heart rhythm. The primary users of AEDs are first responders and hospital health care providers.
The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected.
The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death.
The catalog numbers of the recalled adult or adult/child radiotransparent electrodes, manufactured by Heart Sync, Inc., of Ann Arbor, MI, are C100-Philips, C100AC-Philips, T100LO-Philips, T100-Philips and T100AC-Philips. These AED electrodes were distributed between October 26, 2011, and November 26, 2014.
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