LifePak CR Plus Automated External Defibrillators Recalled by Physio Control, Inc.
September 12th, 2008 laurie
The FDA has announced a Class 1 recall of LifePak CR Plus Automated External Defibrillators, product numbers 3200731-003 and 3200731-027, for a manufacturing defect which could result in death. 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).
These devices are used by emergency or medical personnel, or by others who have taken the appropriate training to use this AED. The devices are intended to treat adults in cardiopulmonary arrest (heart attack). They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
According to the FDA release, 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: 1) Remove the affected AEDs from service or 2) Remove and discard the shock button cover.
