BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2983276 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00291
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    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 EVAL 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 EXPOSING WIRES. UPON EVALUATION, THE YELLOW (PGND) AND BLACK PULSE WIRES WERE OPEN IN THE TRUNK CABLE CONNECTOR. IN ADDITION, THE J704 CONNECTOR WAS CHARRED. THE CAUSE OF THE SERVICE CODE 2044 IS THE OPEN WIRES IN THE TRUNK CABLE CONNECTOR AND THE DAMAGED J704 CONNECTOR. THE CAUSE OF THE OPEN WIRES IS A DAMAGED TRUNK CABLE CONNECTOR. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. THE ROOT CAUSE OF THE DAMAGED J704 CONNECTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47367 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR