BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 922509 · Received October 2, 2007

    Report

    Report Number
    3002158293-2007-00175
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    July 3, 2007
    Report Date
    October 1, 2007
    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 REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE "CHECK BELT" MESSAGES WAS A COLD SOLDER JOINT ON THE PC BOARD FOR ECG B. THE ROOT CAUSE OF THE COLD SOLDER JOINT CANNOT BE CONFIRMED. THE DAMAGED ELECTRODE BELT WAS REPAIRED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE DEVICE WOULD HAVE FUNCTIONED WITH SINGLE LEAD DETECTION. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE DAUGHTER OF A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER MOTHER IS RECEIVING "CHECK BELT" MESSAGES CONSTANTLY. SUPPORT REQUESTED A DOWNLOAD AND THE DOWNLOAD REVELED A LARGE AMOUNT OF BACK FALLOFF. PATIENT'S DAUGHTER TOLD SUPPORT THAT THE ELECTRODES WERE TOUCHING THE PATIENT'S BODY. SUPPORT SENT PATIENT 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 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR