BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2041494 · Received March 10, 2011

    Report

    Report Number
    3002158293-2011-00272
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 7, 2011
    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/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT FUNCTIONING PROPERLY) WAS CONFIRMED. UPON EVALUATION, THE POWER BRICK CONNECTOR WAS FOUND TO BE DAMAGED AND WOULD NOT STAY CONNECTED TO THE CHARGER. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER BRICK. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM WOULD ONLY WORK IF THE CORD WAS HELD IN PLACE. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR