BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4002196 · Received July 3, 2014

    Report

    Report Number
    3008642652-2014-02098
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 204) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THE YELLOW (PGND) WIRE WAS OPEN INSIDE THE TRUNK CABLE. THE CAUSE OF THE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE ELECTRODE BELT AND MONITOR. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS THE OPEN WIRE. THE ROOT CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392394 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR