BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6120518 · Received November 22, 2016

    Report

    Report Number
    3008642652-2016-08169
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. UPON EVALUATION, THE Q10 TRANSISTOR AND V1 MOV WERE SHORTED ON THE DEFIBRILLATOR BOARD. THE CAUSE OF THE TEST FAILURE IS THE SHORTED Q10 TRANSISTOR AND SHORTED V1 MOV. THE ROOT CAUSE OF THE SHORTED COMPONENTS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENTS 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
    772478 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other