BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2860450 · Received November 5, 2012

    Report

    Report Number
    3008642652-2012-02892
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (POWER SUPPLY CORD WILL NOT ATTACH TO CHARGER) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT CHARGE. UPON EVALUATION, THE POWER UNIT CONNECTOR WAS DAMAGED. THE CAUSE OF THE INABILITY TO CONNECT WITH THE CHARGER AND THE INABILITY TO CHARGE IS THE DAMAGED POWER SUPPLY CONNECTOR. THE ROOT CAUSE OF THE DAMAGED POWER SUPPLY CONNECTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER POWER SUPPLY CORD WOULD NOT STAY IN THE CHARGER WITHOUT BEING HELD. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR