BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6340590 · Received February 17, 2017

    Report

    Report Number
    3008642652-2017-01437
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 19, 2017
    Report Date
    February 17, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED. UPON EVALUATION THE MONITOR WAS RESETTING DURING PULSE TESTING 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

    A US DISTRIBUTOR RETURNED A MONITOR INDICATING THAT IT WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123691 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1