BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4172788 · Received September 19, 2014

    Report

    Report Number
    3008642652-2014-02962
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON) WAS CONFIRMED. AS RECEIVED, THE POWER SUPPLY WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO POWER ON IS THE DEFECTIVE POWER SUPPLY. THE ROOT CAUSE OF THE DEFECTIVE POWER SUPPLY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) TO REPORT THAT THE BATTERY CHARGER/MODEM WAS UNABLE TO POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582955 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA