BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4080967 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02129
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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/MODEM WON'T POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO POWER ON. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE POWER SUPPLY BRICK. THE ROOT CAUSE FOR THE DEFECTIVE POWER BRICK COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY BRICK. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A CHARGER/MODEM THAT WOULD NOT POWER UP. THE PSR WAS SENT A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400954 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA