BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1034040 · Received April 24, 2008

    Report

    Report Number
    3002158293-2008-00171
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 23, 2008
    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 EVAL SUMMARY: DEVICE EVAL ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE A BROKEN WIRE IN THE TRUNK CABLE. THERE WERE CUTS IN THE INSULATION OF MANY WIRES. THESE BROKEN WIRES CAUSED THE "ADJUST BELT" MESSAGES. THE ROOT CAUSE OF THE BROKEN WIRES APPEARS TO BE MISUSE. THERE WERE CUTS NOTED ON THE TRUNK CABLE. THE CABLE LOOKED TO HAVE TOOL MARKS ON IT THAT CAUSED THE TEARS IN THE INSULATION. THE ELECTRODE BELT WAS REPAIRED, RETESTED AND RESTOCKED. THE ELECTRODE BELT TRUNK CABLE WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE ELECTRODE BELT TRUNK CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING "CHECK BELT MESSAGES". SUPPORT HAD THE PT CHECK THE ELECTRODE BELT CONNECTION WITH THE MONITOR. SUPPORT THEN REQUESTED A MANUAL RECORDING AND DOWNLOAD. THE DOWNLOAD REVEALED FALLOFF ON ALL LEADS, YET THE MANUAL RECORDING HAD CLEAR SIGNAL ON BOTH CHANNELS. 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 63 YR