BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2033083 · Received February 28, 2011

    Report

    Report Number
    3002158293-2011-00226
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 24, 2011
    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 SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BROKEN TRUNK CONNECTOR) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THERE WERE NO CUT WIRES. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DURING SERVICING OF ELECTRODE BELT SN (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PROBLEM WAS DISCOVERED. THE BELT WAS FOUND TO HAVE A BROKEN TRUNK CABLE CONNECTOR. 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 36 YR