BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2232923 · Received July 22, 2011

    Report

    Report Number
    3008642652-2011-00279
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADD GEL OR REPLACE BELT MESSAGE) HAS BEEN CONFIRMED. UPON INSPECTION, THE GEL FIRE WIRE WAS CUT, RESULTING IN AN OPEN CIRCUIT WHICH CAUSED THE "ADD GEL" MESSAGE. THE ROOT CAUSE OF THE CUT GEL FIRE WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO PHYSICAL TRAUMA. NO ADVERSE EVENT RESULTED FROM THE CUT GEL FIRE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S DEVICE WAS TELLING HIM TO "ADD GEL OR REPLACE BELT." 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 47 YR