Company: Physio Control, Inc
Date of Enforcement Report 8/23/2008
Class:l
PRODUCT
LifePak CR Plus Automated External Defibrillator
Product Number: 3200731-003 and 3200731-027
This device was manufactured from May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007.
REASON
The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).
RECALLING FIRM/MANUFACTURER
Physio Control, Inc.
11811 Willows Rd NE
Redmond, Washington 98052-2003.
FDA COMMENT
Physio Control began calling their customers on August 28, 2008 and
– described the problem of the covered and invisible shock button, and the inability to provide shock to adults who may be having a heart attack.
– informed their customers that their AEDs would be replaced immediately.
– sent a follow-up letter that was FAXed or emailed the same day stating that the customers should immediately perform one of the following actions:
Remove the affected AEDs from service or
Remove and discard the shock button cover (a diagram showing what to do was enclosed).
The company completed notifying its customers on September 2, 2008
