BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112149 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01193
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (SERVICE CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS CRACKED DAMAGING INTERNAL WIRES. UPON EVALUATION, THE GREEN (3.3V) WIRE WAS OPEN IN THE TRUNK CABLE CONNECTOR. THE CAUSE OF THE SERVICE CODE 204 IS A DISRUPTION IN COMMUNICATION BETWEEN THE MONITOR AND ELECTRODE BELT. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS THE OPEN GREEN WIRE. THE CAUSE OF THE OPEN WIRE IS THE DAMAGED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE 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
    195528 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR