Class 1 Device Recall LIFEPAK CR Plus

• Date Initiated by Firm: August 28, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on March 08, 2013
• Recall Number: Z-2341-2008
• Recall Event ID: 49396
• 510(K)Number: K011144
• Product Classification: Automated external defibrillator - Product Code MJK
• Product: LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. 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.
• Code Information: Part number: 3200731-003, 3200731-027, and A3200731-003. Device Serial Nos:30975799, 30975800, 30976004, 30976005, 30976011, 30976016, 30976020, 30976021, 30976024, 30976025, 30976027, 30976028, 30976030, 30976031, 30976035, 30976042, 30976050, 30976051, 30976052, 30976053, 30976059, 30976060, 30976062, 30976064, 30976066, 30976067, 30976068, 30976071, 30976075, 30976080, 30976081, 30976083, 30976084, 30976087, 30976089, 30976092, 30976093, 30976094, 30976096, 30976105, 30976106, 30976107, 30976110, 30976112, 30976114, 30976122, 30976126, 30976127, 30976129, 30976132, 30976136, 30976139, 30976141, 30976142, 30976143, 30976145, 30976147, 30976148, 30976151, 30976155, 30976157, 30976160, 30976162, 30976163, 30976166, 30976169, 30976171, 30976172, 30976173, 30976177, 30976180, 30976181, 30976182, 30976194, 30976195, 30976197, 30976200, 30976205, 30976207, 30976210, 30976211, 30976216, 30976217, 30976220, 30976224, 30976232, 30976240, 30990985, 31029332, 31029333, 31029334, 31029335, 31029336, 31029337, 31029338, 31029339, 31029340, 31029341, 31029342, 31029344, 31029346, 31029347, 31029348, 31029349, 31029350, 31029351, 31029355, 31029356, 31029357, 31029358, 31029359, 31029360, 31029361, 31029362, 31029363, 31029364, 31029365, 31029367, 31029368, 31029369, 31029371, 31029373, 31029375, 31029377, 31029381, 31029387, 31029390, 31029392, 31029401, 31469750, 34574276, 34634407, 34636114, 34637837, 34637879, 34638012, 34640657, 34641247, 34645809, 34701718, 34705207, 34705216, 34709423, 34709424, 34709425, 34709428, 34709429, 34709435, 34709436, 34709437, 34709442, 34709444, 34709454, 34709459, 34709462, 34709464, 34709475, 34709495, 34709496, 34709503, 34709507, 34709510, 34709513, 34709514, 34709515, 34709525, 34709527, 34709528, 34709531, 34709532, 34709536, 34709537, 34709538, 34709540, 34709542, 34710243, 34710249, 34710256, 34710258, 34710263, 34710265, 34710268, 34710276, 34710278, 34710284, 34710304, 34710307, 34710308, 34710310, 34710311, 34710312, 34710313, 34710318, 34712073, 34712074, 34738595, 34738601, 34738606, 34738610, 34738611, 34738616, 34739021, 34739031, 34739035, 34739040, 34739050, 34739068, 34740405, 34740464, 34740555, 34740565, 34740597, 34741052, 34741073, 34741088, 34741105, 34741106, 34741301, 34741313, 34741318, 34741319, 34741332, 34741341, 34741359, 34741369, 34741373, 34741382, 34741389, 34741392, 34741393, 34741394, 34742520, 34742530, 34742531, 34742538, 34742539, 34742540, 34742542, 34742552, 34742558, 34742609, 34742612, 34742613, 34742614, 34742640, 34742649, 34742652, 34742654, and 34743762.
• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: 800-422-1142 Ext. 5
• Manufacturer Reason for Recall: This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h
• FDA Determined Cause: Employee error
• Action: On 8/28/08 the firm began contacting consignees by telephone and stating that the LIFEPAK CR Plus defibrillators were discomfiture as semi-automatic, and that a responder is unable to press the shock button to deliver therapy when instructed by the AED voice prompt because the shock button is covered and not visible. The consignee was instructed that the unit(s) would be replaced immediately. This phone contact was followed by a letter flagged "'URGENT - MEDICAL DEVICE RECALL" dated August 2008 that was f axed or e-mailed the same day. The letter repeated the information provided in the telephone contact and stated to "Immediately perform one of the following actions: Remove the affected AEDs from service or Remove and discard the shock button cover (see enclosed illustration). Enclosed with the letter is an illustration providing instructions for removal of the auto shock button cover. Customer notification was completed by 9/2/08.
• Quantity in Commerce: 249 units
• Distribution: Worldwide Distribution including USA, and countries of Canada, Germany, and Hong Kong.
• 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 = MJK and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.