BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1472305 · Received June 11, 2009

    Report

    Report Number
    3002158293-2009-00374
    Event Type
    Malfunction
    Date Received
    June 11, 2009
    Date of Event
    May 5, 2009
    Report Date
    June 8, 2009
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B) (4) HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE A DEFECTIVE CABLE FROM ECG B TO THE DISTRIBUTION NODE. THIS CAUSED 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 UNKNOWN, BUT APPEARED TO BE CAUSED BY A CUT IN THE OUTER INSULATION OF THE WIRES. THE ELECTRODE BELT CABLE WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE TERRITORY MANAGER (TM) OF A (B) (6) MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT HAD REPORTED TO HER THAT THE ELECTRODE BELT CONNECTOR HAD BROKE. THE TM VISITED THE PATIENT AND REPLACED 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 63 YR