BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3964487 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01585
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204/ CHECK THERAPY ELECTRODES) WAS CONFIRMED. UPON EVALUATION, THE TRUNK CABLE AND THE CABLE CONNECTING THE REAR THERAPY ELECTRODE (TE) AND THE DISTRIBUTION NODE (DN) WERE PULLED FROM THE DN STRAIN RELIEF, DAMAGING INTERNAL WIRES. THE CAUSE OF THE CHECK THERAPY ELECTRODES MESSAGES AND THE CODE 204 IS THE DAMAGED CABLES AND INTERNAL WIRES. THE ROOT CAUSE OF THE DAMAGED CABLE AND WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLES. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLES AND INTERNAL WIRES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE AND CONSTANT CHECK THERAPY ELECTRODES. THE PATIENT'S DOWNLOAD REVEALED A SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307306 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR