Physio-Control Inc., a wholly-owned subsidiary of Medtronic Inc., has issued a nationwide recall for a limited number of LIFEPAK CR Plus Automated External Defibrillators. The devices are misconfigued with software intended for a different type of external defibrillator, which could cause therapy to be delayed or not delivered at all in a critical emergency situation.
The Medtronic external defibrillator recall applies to 249 of their LIFEPAK CR Plus devices with product numbers 3200731-003 and 3200731-027. These units were manufactured between May 2004 and August 2007, and distributed until December 2007.
Automatic external defibrillators are designed to deliver an electrical shock to people who suffer sudden cardiac arrest to restore normal heart rhythm. They could be used by anyone who has CPR/AED training to provide a defibrillation shock, and they are often placed in public places such as work sites, schools, airports and retail locations. They run on batteries and are portable.
The recalled Medtronic LIFEPAK CR Plus defibrillators are supposed to be automated devices, but they contain software that is intended for semi-automatic external defibrillators. The semi-automated devices use a voice prompt to instruct the responder to press a button to deliver the shock. However, on the automatic defibrillators, the shock button is covered.
A responder using the misconfigured Medtronic defibrillators may be unable to locate the shock button or press it when the device is needed to deliver a life saving therapy. Medtronic has received at least one report of a consumer who had a problem associated with this issue.
Physio-Control, which is a leading provider of external defibrillators for treatment of sudden cardiac arrest, has distributed more than 650,000 LIFEPAK defibrillators worldwide.
A letter was sent to registered customers on August 28, 2008 and the company indicates that free replacement devices were shipped by September 2, 2008. The company warns that any of the defective devices should not be used or the cover of the shock button should be removed and discarded according to instructions provided by Physio-control.
The external defibrillator recall has been categorized by the FDA as a Class 1 Recall, since use of the defibrillator as is, could carry a reasonable probability of serious adverse health consequences or death.