510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2341-2008

LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator...

Physio Control, Inc. / initiated 2008-08-28 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Physio Control, Inc. began a recall of LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2341-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
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.
Product code
MJK Dna Probe, Trichomonas Vaginalis
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
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
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.