BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9853049 · Received March 19, 2020

    Report

    Report Number
    3008642652-2020-02386
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 18, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO UNDERGO INCOMING FUNCTIONALITY TESTING) WAS CONFIRMED. UPON EVALUATION, THE MONITOR WILL NOT POWER UP. THE CAUSE OF THIS SERVICE CODE WAS THAT THE C1 CAPACITOR SHORTED WHICH SHORTED. THE CAUSE OF THE INABILITY TO COMPLETE TESTING AND THE INABILITY TO POWER ON IS THE C1. THE CAUSE OF THE INABILITY TO COMPLETE TESTING AND THE INABILITY TO POWER ON IS THE C1. THE ROOT CAUSE OF THE SHORTED C1 CAPACITOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT A MONITOR WILL NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321662 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1