BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2912825 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03091
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 21, 2012
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) WAS CONFIRMED. UPON INVESTIGATION, THE ELECTRODE BELT FAILED A FALL-OFF AND HIGH POT TEST. THE CAUSE FOR THE TEST FAILURES AND THE REPORTED SERVICE CODE WAS ISOLATED TO AN OPEN YELLOW WIRE (PGND) IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN TRUNK CABLE CONNECTOR WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING SERVICE CODE 204 - BELT/MONITOR UNUSABLE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR