BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1053460 · Received May 28, 2008

    Report

    Report Number
    3002158293-2008-00224
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 27, 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 EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE A DEFECTIVE CABLE FROM ECG C TO THE DISTRIBUTION NODE. THIS CAUSE THE DETERIORATION OF THE SIGNAL. THE CABLE WAS RECONDITIONED AND THE ELECTRODE BELT WAS TESTED. BASELINE EVALUATION WAS PERFORMED, AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE CABLE WAS RETURNED TO STOCK. THE ROOT CAUSE OF THIS DEFECT IS UNK, BUT APPEARED TO BE CAUSED BY STRETCHING OF THE CABLE, DUE TO PT USE. THE ELECTRODE BELT CABLE WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE IS GETTING CONSTANT "CHECK BELT -- SEE MANUAL" MESSAGES. HE SAID THAT HE WAS RECENTLY FIT AND HAS NOT REMOVED FROM BELT FROM THE MONITOR. SUPPORT HAD HIM PERFORM A MANUAL RECORDING AND PERFORM A DOWNLOAD. THE DOWNLOAD REVEALED THAT THE ELECTRODE BELT SIGNAL IS DETERIORATING. SUPPORT SENT A PT SERVICES REP TO REPLACE THE PT'S 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 63 YR