BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4862689 · Received June 18, 2015

    Report

    Report Number
    3008642652-2015-03934
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 17, 2015
    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 OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER RESETS) WAS CONFIRMED. AS RECEIVED, THE CHARGER/MODEM RESETS. UPON EVAL, THE U13 8-BIT CMOS FLASH MICRO-CONTROLLER WAS CORRUPTED. THE CAUSE OF THE CHARGER RESETS IS THE CORRUPTED U13 COMPONENT. THE ROOT CAUSE OF THE CORRUPTED COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED COMPONENT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) TO REPORT THAT THE CHARGE/MODEM RESETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398616 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA