BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2983317 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00296
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 28, 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 (DAMAGED BELT CONNECTOR/ CODE 204) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR WAS DAMAGED. UPON EVALUATION, THE WHITE (DRVN_GND) AND THE RED (CAN H) WIRES WERE OPEN IN THE TRUNK CABLE CONNECTOR. THE CAUSE OF THE CODE 204 IS THE OPEN WIRES. THE CAUSE OF THE OPEN WIRES IS THE DAMAGE TO THE TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. 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) YEAR OLD FEMALE PATIENT'S HUSBAND CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A DAMAGED ELECTRODE BELT CONNECTOR IN ADDITION TO SERVICE CODE 204. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45963 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR