BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121029 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00372
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 13, 2008
    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 MANUFACTURE DATE: MONITOR; ELECTRODE BELT - 05/2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR AND ELECTRODE BELT HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE ELECTRODE BELT WAS FOUND TO HAVE BROKEN WIRES IN THE CABLE FROM ECG C TO ECG D. THERE WAS A SHORT WITHIN THE CABLE. THESE BROKEN WIRES CAUSED THE "ADJUST BELT" MESSAGES. THE ROOT CAUSE OF THE BROKEN WIRES APPEARS TO BE MISUSE. THE ELECTRODE BELT LOOKED TO HAVE BEEN SNAGGED ON SOMETHING FORCIBLY REMOVING THE WIRES FROM THE STRAIN RELIEF. THE ELECTRODE BELT WAS REPAIRED, RETESTED AND RESTOCKED. THE MONITOR WAS FULLY FUNCTIONAL. IT WAS REFURBISHED, RETESTED AND RESTOCKED. THE ELECTRODE BELT CABLE WAS FIXED. NO ADVERSE EVENT RESULTED FROM THE ELECTRODE BELT CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT AND MONITOR.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE DEVICE WAS SIREN ALARMING CONTINUOUSLY. HE STATED THAT WHEN HE RETURNS THE BELT CORD IN DIFFERENT DIRECTION THE DEVICE WILL SIREN ALARM. THE PATIENT ALSO RECEIVED A "CALL AMBULANCE" MESSAGE LAST NIGHT. THE PATIENT INSISTS THAT THE DEVICE IS TIGHT ON HIS BODY. SUPPORT SENT THE PATIENT A REPLACEMENT MONITOR AND 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR