BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1301802 · Received December 5, 2008

    Report

    Report Number
    3002158293-2008-00642
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    September 30, 2008
    Report Date
    December 4, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE ELECTRODE BELT WAS FOUND TO HAVE A DEFECTIVE CABLE FROM ECG B TO THE DISTRIBUTION NODE. THIS CAUSED THE SIGNAL TO BE NOISY AND DISTORTED WHEN THE CABLE WAS MANIPULATED. 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 STRETCHING OF THE CABLE DUE TO PATIENT USE. NO ADVERSE EVENT RESULTED FROM THE FAULTY ELECTRODE BELT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT ELECTRODE BELT WAS MISSING BOTH THE FRONT-TO-BACK AND SIDE-TO-SIDE SIGNAL. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS WITH IT.

    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 NA