BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823147 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01200
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF THE CHARGER/MODEM POWER SUPPLY WAS COMPLETED. UPON EVALUATION, THE POWER SUPPLY BRICK WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO POWER A CHARGER/MODEM WAS 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. AS RECEIVED, THE POWER SUPPLY WAS SEPARATED FROM THE CHARGER/MODEM. THE CHARGER/MODEM ASSOCIATED WITH THIS POWER SUPPLY AT INCOMING IS UNKNOWN.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, A CHARGER/MODEM POWER SUPPLY WOULD NOT POWER THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262500 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA