BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1491081 · Received August 5, 2009

    Report

    Report Number
    3002158293-2009-00593
    Event Type
    Malfunction
    Date Received
    August 5, 2009
    Date of Event
    July 3, 2009
    Report Date
    July 23, 2009
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B) (4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE BROKEN WIRES IN THE TRUNK CABLE. THE JACKET HAD HOLES IN IT AS IF SOMEONE HAD TRIED TO CUT IT. THESE INTERNAL SHORTS CAUSED NOISE IN BOTH THE SIDE-TO-SIDE AND FRONT-TO-BACK CHANNELS. THE MONITOR SIGNAL WOULD ALSO GET SHORTED WHEN THIS CORD WAS MANIPULATED. THE ROOT CAUSE OF THE SHORTED WIRES CANNOT BE POSITIVELY IDENTIFIED, BUT APPEARS TO BE MISUSE. THE ELECTRODE BELT WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE ELECTRODE BELT CABLE PROBLEM. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B) (6) FEMALE PT CALLED TO REPORT THAT SHE WAS GETTING CONSTANT "ADJUST BELT" MESSAGES. SUPPORT HAD HER ENSURE ALL THE ELECTRODES WERE TOUCHING HER BODY. THERE WERE. SUPPORT HAD HER PERFORM TWO MANUAL RECORDINGS AND DOWNLOAD. THE DOWNLOAD REVEALED A FLAT FB CHANNEL AND A SS CHANNEL THAT LOOKED TO BE FINE. SUPPORT SENT THE PT 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR