BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINLAB

    MDR report key: 598009 · Received April 7, 2005

    Report

    Report Number
    598009
    Event Type
    Other
    Date Received
    April 7, 2005
    Date of Event
    May 28, 2004
    Report Date
    March 17, 2005
    Manufacturer
    BRAINLAB, INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIST FROM THE RADIOLOGICAL PHYSICS CENTER WAS MEASURING THE RADIATION PARAMETERS OF THE NOVALIS UNIT. THE MEASUREMENTS SHOWED A RADIATION OUTPUT GREATER THAN FACILITY HAD STATED AS THE CORRECT RADIATION OUTPUT. UPON REVIEW OF FACILITY'S CALCULATION SPREADSHEET, A DATA ERROR WAS FOUND. THE SPREADSHEAT REQUIRES THE RATIO TO BE ENTERED IN TWO LOCATIONS. DURING THIS CALIBRATION, THE RATIO OF 0.662 WAS ONLY ENTERED IN ONE OF THOSE LOCATIONS, AND, CONSEQUENTLY, THE DOSE WAS UNDERESTIMATED. THEREFORE, WHEN THE DOSE WAS ADJUSTED TO DELIVER A 1.0 CGY/MU AT THE REFERENCE VIA THE SPREADSHEET, THE ACTUAL OUTPUT WAS APPROX 1.5 CGY/MU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB NOVALIS SHAPED BEAM SURGERY SYSTEM IYE BRAINLAB, INC. NOVALIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other