BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7457980 · Received April 25, 2018

    Report

    Report Number
    3008642652-2018-03701
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 18, 2018
    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 SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESET) HAS BEEN CONFIRMED. THE MONITOR RESET DURING A PULSE TEST. 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
    305173 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1