LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It

FDA device recall Z-2341-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Physio Control, Inc.

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

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

MJK

Quantity affected

249 units

Distribution

Worldwide Distribution including USA, and countries of Canada, Germany, and Hong Kong.

Date initiated

2008-08-28

Date posted

2008-09-16

Date terminated

2013-03-08

Location

Redmond, WA

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