BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5836156 · Received August 1, 2016

    Report

    Report Number
    3008642652-2016-05184
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 5, 2016
    Report Date
    August 1, 2016
    Manufacturer
    ZOLL MANUFACTURING 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESET DURING A PULSE TEST) HAS BEEN CONFIRMED. THE MONITOR RESET DURING A PULSE TEST AT THE DISTRIBUTOR. THE ROOT CAUSE FOR THE RESETS WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON 11/06/2015. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    UPON EVAULATION OF MONITOR SN (B)(4) A PULSE TEST RESET WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490414 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1