BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9728624 · Received February 19, 2020

    Report

    Report Number
    3008642652-2020-00941
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 5, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED AN ELECTRODE BELT AND REPORTED THAT THE BELT WAS UNABLE TO COMPLETE INCOMING FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194087 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1