Class 2 Device Recall LIFEPAK Express AED

• Date Initiated by Firm: July 24, 2008
• Date Posted: October 30, 2008
• Recall Status: Terminated on August 08, 2013
• Recall Number: Z-0150-2009
• Recall Event ID: 49056
• 510(K)Number: K011144
• Product Classification: Automated External Defibrillator - Product Code MKJ
• Product: LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges.; ; LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
• Code Information: PART NUMBER: 3202177-000, 3202177-001, 3202177-002, 3202177-006, 3202177-024, 3202177-026, 3202177-046, 3202177-066, 3202177-080, 3202177-086, and 3202177-106; SERIAL NUMBER: 35057999, 35558399, 35057996, 35076760, 35086872, 35086873, 35086874, 35086875, 35086876, 35086877, 35086878, 35086879, 35086880, 35086881, 35087002, 35087003, 35087004, 35112123, 35120681, 35120682, 35120683, 35174476, 35174477, 35174478, 35174479, 35174487, 35189989, 35190004, 35190371, 35190372, 35237901, 35363559, 35388553, 35415805, 35457181, 35606013, 35627387, 35667618, 35702342, 35843530, 36084979, 36106000, 35086839, 35142569, 35142570, 35142571, 35142572, 35142573, 35142574, 35266844, 35266845, 35266878, 35266879, 35266881, 35266883, 35266884, 35266886, 35266887, 35266888, 35266889, 35266890, 35266891, 35266892, 35266893, 35266899, 35266900, 35314291, 35416139, 35450316, 35450324, 35058947, 35058948, 35058949, 35058950, 35058951, 35058952, 35058953, 35058954, 35058956, 35058958, 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• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: 425-867-4000 Ext. 4644
• Manufacturer Reason for Recall: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 07/24/08, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter with a confirmation sheet via certified return receipt to customers. The letter notified the customer of the recall and the hazard associated with the recall and provided instructions to customers: 1) Immediately verify the AED powers on and voice prompts begin. After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. 2) Keep the AED in use and perform monthly inspections that include the additional AED power on test. Perform a monthly inspection which is consistent with the device labeling. 3) If "OK" is visible on the Readiness Display and AED powers on, it is ready for use. 4) If, at any time, the AED does not power on or if any other indicator displays (i.e. battery or CHARGE-PAK symbol, attention symbol or wrench symbol) immediately call Physio-Control Technical Support (1-800-442-1142). The letter advises customers a Physio-Control representative will contact them within 60 days to arrange a replacement. A confirmation sheet was sent with the letter; to be returned to Physio-Control, Inc. For specific questions or additional information, contact Physio-Control, Inc. at 1-800-442-1142 weekdays between 6:00 a.m. and 4:00 p.m. (PST) or at www.physio-control.com.
• Quantity in Commerce: 2,230 Units
• Distribution: Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
• 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 PHYSIO-CONTROL CORP.