BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2091421 · Received May 6, 2011

    Report

    Report Number
    3002158293-2011-00525
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 5, 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGE E-BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVALUATION THE TRUNK CONNECTOR WAS DAMAGED, CONNECTOR PINS WERE BENT AND THE LOCKING NUT WAS MISSING. THE CAUSE FOR THE DAMAGED CONNECTOR, BENT PINS AND MISSING LOCKING NUT CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S ELECTRODE BELT CONNECTOR WAS DAMAGED. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR