BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4093046 · Received September 10, 2014

    Report

    Report Number
    3008642652-2014-02779
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (UNABLE TO PERFORM DETECT AND TREAT) WAS CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. UPON INVESTIGATION, THE MONITOR'S CA BOARD HAD EXTENSIVE THERMAL DAMAGE TO MULTIPLE COMPONENTS. THE CAUSE OF THE TEST FAILURE WAS THE THERMALLY DAMAGED CA BOARD. THE ROOT CAUSE OF THE DAMAGED BOARD CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT MONITOR SN (B)(4) WAS UNABLE TO PERFORM THE DETECT AND TREAT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559653 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA