BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE 3

    MDR report key: 268097 · Received March 7, 2000

    Report

    Report Number
    2916556-2000-00245
    Event Type
    Malfunction
    Date Received
    March 7, 2000
    Date of Event
    January 19, 2000
    Report Date
    March 2, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY ADAC QA THAT THE LABELING OF PT ORIENTATION IS HARD CODED IN THE FOLLOWING FEATURES. THESE DIRECTION LABELS DO NOT CHANGE WHEN THE PT ORIENTATION IS CHANGED AND THIS COULD LEAD TO USER ERROR. 1)POI SPREADSHEET. 2)LASER LOCALIZATION WINDOW. 3)DATASET SPECIFICATIONS WINDOW. 4)DIGITIZATION. 5)ANGIOGRAPHIC FRAME 6)BRACHY FILM RECONSTRUCTION. ALSO, THE COORDINATES (X,Y,Z,) ARE REFERENCED IN SOME FEATURES WITHOUT THE ADDITIONAL CLARIFICATION THAT THESE ARE RELATIVE TO THE CT COORDINATE SYSTEM. THE FEATURES MISSING THIS CLARIFICATION ARE: 1)ROI SPREADSHEET. 2)EDIT CONTOUR WINDOW. 3)COPY CONTOUR WINDOW. 4)DIGITIZER COORDINATE WINDOW. THIS WAS REPORTED BY IN-HOUSE QA, NOT A USER SITE. NO PTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 3 RADIATION THERAPY PLANNING EQUIPMENT IYE ADAC LABORATORIES 9200-0555A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *