BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULOC SYSTEM

    MDR report key: 1052607 · Received May 22, 2008

    Report

    Report Number
    3025265-2008-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 15, 2008
    Manufacturer
    NORTHWEST MEDICAL PHYSICS EQUIPMENT
    Product Code
    IYE
    PMA / PMN Number
    K904908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING TECHNICIAN WAS ABLE TO REPRODUCE THE ERROR WITH THE ORIGINAL DATA, BUT THE ROOT CAUSE WAS NOT APPARENT. SOFTWARE ENGINEERS WERE ABLE TO RECREATE THE PROBLEM BY CHANGING THE DRR GANTRY ANGLE IN THE VIEW DRR - DRR VIEWER AND INITIALIZERON SCREEN. IN THIS DIALOG SCREEN THE DRRS FOR THE PT HAVE BEEN ACCEPTED EARLIER, THEN SELECTING THE CANCEL OR CLOSE FORM BOX WILL CAUSE THE UP/DOWN FIELD TO BECOME INVERTED AND THE LOCALIZATION MOVE WILL BE INCORRECT. THE PROBLEM: WHEN THE CANCEL BUTTON IS SELECTED TO GO FORWARD THAT THE SYSTEM DOES NOT UPDATE THE FILES CONTAINING THE DRR GANTRY ANGLE INFO, OR SFD, HOWEVER, THE PORTAL IMAGE MARKER DOES USE THE INFO FROM MEMORY. NO PTS WERE ACTUALLY TREATED AS THIS ISSUE WAS IDENTIFIED AT SET-UP. WE WILL SEND A NOTIFICATION LETTER TO ALL USERS OF THE SOFTWARE IDENTIFYING THIS BUG AND THE ACTIVITIES NECESSARY TO WORK AROUND IT. THE SOFTWARE WILL ALSO BE CORRECTED TO ELIMINATE THIS PROBLEM ON THE NEXT RELEASE VERSION.

    Description of Event or Problem · 1

    COUCH MOVES REPORTED IN PORTAL IMAGE VIEWING WINDOW SHOWED AN UP SHIFT OF 7 MM AND COUCH MOVES WINDOW SHOWED A MOVE OF DOWN 7 MM. THIS REPRESENTS A COMPLETE OPPOSITE SHIFT FROM ONE REPORTING SCREEN TO ANOTHER. THIS IS CURRENTLY SHOWING THIS BEHAVIOR FOR TWO PTS. RECREATING THE PTS' DATA INFO SOLVED THE ISSUE. CUSTOMER DID NOT TREAT PTS BASED ON THE CONFLICTING SHIFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCULOC SYSTEM ISOLOC SOFTWARE IYE NORTHWEST MEDICAL PHYSICS EQUIPMENT VER 6.6 10302006

    Patients

    Seq Age Sex Outcome Treatment
    1