BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4232482 · Received September 17, 2014

    Report

    Report Number
    3008642652-2014-02746
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    May 29, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT POWER ON) HAS BEE CONFIRMED. AS RECEIVED, THE CHARGER/MODEM WOULD NOT POWER ON. UPON EVALUATION, THE POWER SUPPLY UNIT WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO POWER ON IS THE DEFECTIVE POWER SUPPLY UNIT. THE ROOT CAUSE OF THE DEFECTIVE POWER SUPPLY UNIT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE CHARGER/MODEM WAS REPLACED.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR RETURNED A CHARGER/MODEM INDICATING THAT IT WOULD NOT POWER ON. THE CHARGER/MODEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574488 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA