BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2160483 · Received July 1, 2011

    Report

    Report Number
    3008642652-2011-00122
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 22, 2011
    Report Date
    June 30, 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 (BACKLIGHT NOT WORKING) WAS CONFIRMED. UPON EVALUATION, THE BATTERY CHARGER/MODEM WOULD NOT POWER ON. THE CAUSE FOR THE CHARGER/MODEM NOT POWERING UP WAS A DEFECTIVE POWER BRICK. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CANNOT BE POSITIVELY IDENTIFIED. 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) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY CHARGER/MODEM BACKLIGHT WAS NOT WORK. THEREFORE, SHE WAS UNSURE WHETHER HER BATTERIES WERE CHARGING. 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 39 YR