Automated External Defibrillators - FDA Classifies As A Class I Action An Urgent Medical Device Correction By Physio-Control

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Sep 2008 - 4:00 PDT

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Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc. (NYSE: MDT) announced the FDA has classified as a Class I action the company's recently initiated and completed voluntary urgent medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs). Certain fully automated devices manufactured from May 2004 through April 2007 are mis-configured with the software intended for semi-automatic AEDs. With this configuration set up, if the responder is instructed to press the shock button to deliver therapy, they will not be able to locate the shock button because it is covered in the fully automated device. In this situation, it is possible that therapy could be delayed or not delivered at all; possibly resulting in death. There has been one patient related complaint associated with this issue.

As of September 2, 2008, the company has notified all affected customers and shipped replacement devices at no charge. During the brief interval while customers awaited receipt of replacement devices, Physio-Control recommended that customers with the identified, affected defibrillators either remove the affected AED(s) from service or remove and discard the shock button cover (instructions provided).

If customers have questions or would like additional information they should contact Physio-Control Technical Support. Customers may also visit the company's website at http://www.physio-control-notices.com/config for more information or to enter the serial numbers of their devices to determine if they are affected by this action.

About the LIFEPAK CR Plus AEDs

The LIFEPAK CR Plus automated external defibrillators (AEDs) are battery operated and portable. These AEDs are placed in public access environments such as schools, airports, city halls, retail locations and workplaces. Anyone with minimal CPR/AED training can use an AED to provide a defibrillation shock to someone in sudden cardiac arrest.

About Physio-Control

Physio-Control is located in Redmond, Wash. Physio-Control pioneered defibrillation technology over 50 years ago. With more than 650,000 LIFEPAK® defibrillators distributed worldwide, the company is the world's leading provider of external defibrillators for the treatment of sudden cardiac arrest. To find out more about Physio-Control, go to http://www.physio-control.com.

Physio-Control