|LifePak CR Plus Automated External Defibrillators is being recalled. Image Source: Physio-Control|
Physio Control, a subsidiary of Medtronic, has issued a recall of its LifePak CR Plus automated external defibrillators (AED) used by emergency or medical personnel to treat adults in cardiopulmonary arrest.
The device is being recalled because it instructs the responder, by voice prompts, to press the shock button, which is covered and not visible. Therefore, the responder is not able to provide shock therapy, according to the FDA.
The agency said that the AED should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
According to the FDA, the device was manufactured from May 20, 2004 through Aug. 11, 2007 and distributed from May 20, 2004 through Dec. 4, 2007.
The Redmond, Wash.-based Physio-Control began calling their customers on Aug.28 to:
- Describe the problem of the covered and invisible shock button, and the inability to provide shock to adults who may be having a heart attack; and
- Inform their customers that their AEDs would be replaced immediately.
The company sent a follow-up letter that was faxed or emailed the same day stating that customers should immediately perform one of the following actions—remove the affected AEDs from service, or remove and discard the shock button cover.
The company said it completed notifying its customers on Sept. 2.
In its notification, the FDA said that healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
In May, top executives of Physio-Control signed a permanent injunction issued by the FDA related to AED, which prohibited the manufacture, distribution and export of specified AEDs at or from Physio-Control’s facility in Redmond, Wash., until the devices and facilities proved to be in compliance with the agency's current good manufacturing practice requirements.