BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1011942 · Received March 11, 2008

    Report

    Report Number
    3002158293-2008-00091
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    November 1, 2007
    Report Date
    March 10, 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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE MONITORS RESPONSE BUTTONS WORKED CORRECTLY IN SERVICE. THE MONITOR'S RESPONSE BUTTONS WERE REPLACED AS A PRECAUTION. THE MONITOR WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE RESPONSE BUTTON PROBLEM. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    LIFECOR CUSTOMER SUPPORT NOTICED MANY "TRACE CODE 5" FLAGS IN A DOWNLOAD BY A MALE PATIENT. SUPPORT CONTACTED ENGINEERING TO SEE IF ANY ACTION SHOULD BE TAKEN. ENGINEERING STATED THAT THE MONITOR WAS PROGRAMMED TO DISPLAY MORE FLAGS THAN NORMAL. EVERY TWENTY MINUTES THIS FLAG WILL BE DISPLAYED, BUT IT WILL NOT EFFECT MONITORING OR TREATMENT. AT THIS TIME THERE WAS NO NEED TO EXCHANGE THE EQUIPMENT. IN 2008, THE PATIENT CONTACTED SUPPORT TO REPORT THAT HIS RESPONSE BUTTONS WERE NOT FUNCTIONING. HE STATED HE TRIED MULTIPLE TIMES, WITH BOTH BATTERY PACKS, BUT THE MONITOR WOULD NOT START UP. SUPPORT SENT THE TERRITORY MANAGER (TM) TO THE PATIENT TO EXCHANGE THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR