Physio-Control, a wholly owned subsidiary of Medtronic, has initiated a field correction on certain Lifepak 20/20e defibrillator/monitors manufactured prior to January 9, 2009. The analysis has verified a possible battery (DC) power malfunction on the affected devices, 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 was 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.
Physio-Control said that if AC power is not available when there is a loss of DC power during patient use, the delivery of defibrillation therapy is expected to delay which could result in serious injury or death.
Physio-Control has been in the process of notifying all affected US 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).
Brian Webster, president of Physio-Control, said: “Physio-Control is committed to provide the highest quality devices, ensuring patient safety, and minimising the impact to our customers’ operations. The Lifepak 20/20e monitor is one of our most reliable hospital products and this product correction will make these devices even more reliable.”
Physio-Control recommends customers to keep units in service and to continue testing their Lifepak 20/20e devices frequently and regularly, in accordance with the operating instructions (Section 7 – Maintaining the Equipment).
Physio-Control also advices to keep normally functioning devices in service connected to AC Power and continually charging DC power whenever possible. Physio-Control service representatives are scheduling service visits to update all affected devices.