BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2231362 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00299
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 26, 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT TRUNK CABLE WAS CUT AND THE TRUNK CONNECTOR PINS WERE BENT. THE CUT TRUNK CABLE RESULTED IN AN OPEN CIRCUIT IN THE BELT. THE ROOT CAUSE FOR THE DAMAGE TRUNK CABLE AND BENT TRUNK CONNECTOR PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE AND BENT TRUNK CONNECTOR PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS DEVICE WAS TELLING HIM TO CHECK HIS BELT. THE PATIENT WAS PROVIDED WITH 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 53 YR