Class 2 Device Recall LIFEPAK 1000

• Date Initiated by Firm: February 27, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on March 07, 2011
• Recall Number: Z-1656-2008
• Recall Event ID: 46918
• 510(K)Number: K042404
• Product Classification: Portable defibrillator - Product Code MKJ
• Product: LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.; ; Affected part numbers: 320371500021 through 320371500038, 320371500043, 320371500044, 320371500046, 320371500048, 320371500050, 320371500056, 320371500058, 320371500063, and 320371500067.
• Code Information: Domestic: 35223068, 35267516, 35267519, 35892406, 35895430, 35242436, 35892542, 35977949, 35267533, 35267553, 35910136, 35972647, 35972648, 35972649, 35972650, 35972651, 35972652, 35972653, 35942190, 35942193, 35938673, 35223075, 35969804, 35969805, 35926650, 35926651, 35926652, 35926653, 35926654, 35926655, 35926562, 35967657, 35967658, 35967659, 35967660, 35967661, 35967664, 35967665, 35967666, 35967667, 35969810, 35969811, 35969812, 35969813, 35972478, 35972479, 35972480, 35972481, 35972482, 35904997, 35973187, 35974263, 35974264, 35974265, 35974266, 35974267, 35974268, 35969073, 35969090, 35969091, 35969092, 35969093, 35969094, 35969095, 35969096, 35969097, 35969098, 35969099, 35969100, 35969101, 35969102, 35969103, 35969104, 35969105, 35972621, 35972622, 35972623, 35972624, 35972625, 35965677, 35965678, 35965679, 35965680, 35965682, 35965684, 35965685, 35965688, 35965689, 35965690, 35967568, 35988737, 35988738, 35988739, 35988740, 35223108, 35223112, 35223114, 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• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Todd Bandy; 425-867-4514
• Manufacturer Reason for Recall: Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.
• FDA Determined Cause: Component change control
• Action: On February 27, 2008 the firm sent a URGENT MEDICAL DEVICE NOTIFICATION letter to consignees advising of the issue. The letter states the firm is performing accelerated function testing and that a follow up notification will be sent if the firm's final test results indicate further action is necessary. The letter recommends consignees "Continue to use your LIFEPAK 1000 defibrillator/monitor Set your device to Auto-Analyze Contact Physio-Control immediately if your display begins to dim or goes blank. What to do if the display goes blank while in use: 1. Continue to use the device to treat the patient. (voice prompts and tones function normally). 2. If the device is not set to Auto-Analyze use the lower right soft key to select Analyze from the display screen... 3. All other buttons are labeled outside the display screen." If you have any question contact technical support at 1-800-442-1142 - option 5 or visit the web site at www.physio-control-notices.com/LP1000.
• Quantity in Commerce: 1,647 total - 426 US, 1,221 international
• Distribution: Worldwide Distribution --- including USA and countries of Netherlands, Germany, Australia, Hong Kong, Barbados and Brazil.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.