Physio-Control Launches Class I Recall For LIFEPAK® 20/20e Defibrillators
On July 2, 2010, Physio-Control, a wholly-owned subsidiary of Medtronic Inc., issued a class 1 recall alert for its Lifepak 20/20e defibrillators upon order from the U.S. Food and Drug Administration. In April 2010, the FDA issued a Class I recall of the company’s LifePak 15 product.
Analysis conducted by Physio-Control verified a possible battery (DC) power malfunction on the affected Lifepak/20/20e devices. In the malfunction scenario, a loss of battery power may occur while the unit is in operation. The company says that the loss of DC power during patient use is highly unlikely, but if it occurs and AC power is not readily available, it could delay the delivery of defibrillation therapy, which could potentially result in serious injury or death.
Recommendations:
All customers may visit the company’s website to determine if a device is defective. For customers outside the U.S., please contact your local Medtronic Physio-Control representative. Physio-Control also recommends customers ensure the notification is forwarded to all of their sites. If customers no longer have a LIFEPAK 15 monitor/defibrillator, they are instructed to call Physio-Control as soon as possible.
The LIFEPAK 20/20e defibrillator/monitor was designed with a dual power supply system. The primary source of power is wall (AC) power, which remains available in the event of the loss of battery power. If a malfunction of battery power occurs, customers can plug the device into wall (AC) power to relieve the reliability issue.
Next Steps:
Physio-Control is in the process of notifying all affected U.S and global customers by Certified Mail. The plan is to update all affected power supplies at no charge, during one field service update at the customer site (in most geographies).
Please view the following for more information and in-depth instructions:
