Physio-Control Field Correction to LIFEPAK(R) 20/20e Defibrillator/ Monitors
7/6/2010 1:17:27 PM
MINNEAPOLIS--(BUSINESS WIRE)--Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT), announced the company’s recent initiation of a field correction on certain LIFEPAK 20/20e defibrillator/monitors manufactured prior to January 9, 2009. Analysis conducted by Physio-Control verified a possible battery (DC) power malfunction on the affected devices. In the malfunction scenario, a loss of battery power may occur while the unit is in operation. 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. A 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. While there have been reports of failures during patient use, over the eight year product life, there has been one unconfirmed adverse patient event.
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