BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1106728 · Received August 7, 2008

    Report

    Report Number
    3002158293-2008-00349
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    June 12, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE A SHORT CIRCUIT IN ECG B. THE -5VOLT SUPPLY LINE WAS DISTORTING THE OTHER SIGNALS WITHIN THE ECG. THE SHORT WAS FIXED. THE ELECTRODE BELT WAS REFURBISHED. BASELINE EVAL WAS PERFORMED AND THE CARDIAC SIGNAL NOW APPEARS NORMAL. THE ELECTRODE BELT WAS RETURNED TO STOCK. THE ROOT CASE OF THIS SHORT CIRCUIT IS UNK, BUT IS LIKELY DUE TO STRAIN PLACED ON THE CABLE. THE ELECTRODE BELT SHORT CIRCUIT WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE LIFECOR TERRITORY MANAGER (TM) OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT IS RECEIVING CONSTANT "ADJUST BELT" MESSAGES. HE STATED THAT THE BELT IS CORRECTLY POSITIONED AND THE ECGS ARE SITTING ON THE BODY. HE ALSO STATED THAT THE GARMENT FIT SNUGGLY. SUPPORT REVIEWED THE DOWNLOAD AND RECOMMENDED REPLACING THE 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 UNK