BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3960909 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01567
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 REC'D, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THE TRUNK CONNECTOR WAS CRACKED AND THE YELLOW (PGND) WIRE WAS OPEN THE TRUNK CABLE. THE CAUSE OF THE CODE 204 IS THE OPEN YELLOW WIRE. THE ROOT CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED, BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE AT THE CONNECTOR. 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) YEAR OLD FEMALE 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
    307307 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR