BEUDAMED
    FDA Recall Terminated

    Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. Brand names: Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED.

    Recall: Z-3265-2011 · Initiated June 30, 2011

    Recall

    Recall Number
    Z-3265-2011
    Event Number
    59303
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2011
    Posted
    September 19, 2011
    Terminated
    February 13, 2014
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021-8969

    Description

    Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. Brand names: Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED.

    Reason

    Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro

    Action

    Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly. CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED. Customers can call Cardiac Science at 800-426-0337 or e-mail at [email protected].

    Distribution

    Worldwide Distribution - US (nationwide) This action applies only to domestic

    Quantity

    195,739 units in US