A recall has been issued for the LIFEPAK 15 defibrillator by Physio-Control, Inc. after it was determined that the defibrillators could turn off and on by themselves, potentially resulting in injury or death.
The FDA issued a Lifepak 15 defibrillator recall alert this week, indicating that the action is a class 1 recall, meaning that there is a reasonable chance that the devices could cause serious injury or death. Class 1 recalls are the most serious type of medical device recall.
Physio-Control, Inc., a division of Medtronic, sent a letter to customers in March informing them that they should keep using the devices, but should test them according to operating instructions. The company also told customers that it was sending local representatives for service visits within 60 days. The company referred to the action as a “voluntary correction.” The FDA classified it as a Class 1 recall.
Physio-Control’s announcement says that the problem involves an internal component in the defibrillators, which could inadvertently contact the power printed circuit board assembly. This can cause the device to turn off and on by itself, or turn itself on and not respond to being turned back off. There have been no reported injuries associated with the defective LIFEPAK defibrillators.
The defibrillator recall affects certain LIFEPAK 15 Monitor/Defibrillators by Physio-Control Inc. that were manufactured between March 26, 2009 and December 15, 2009. The recall is limited to a specific set of serial numbers. Customers can perform a search for their device’s serial number on the company’s defibrillator recall announcement.
The company believes it has contacted all customers who purchased the affected devices and is scheduling service visits to repair the problem. Customers who experience the power problems should contact the company’s technical support at 1-800-442-1142.
The FDA requests that any health care professionals or consumers who experience problems with this device report the incident to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.