BEUDAMED
    FDA Adverse Event Other Summary report: N

    AW

    MDR report key: 859858 · Received March 16, 2007

    Report

    Report Number
    9611343-2007-00015
    Event Type
    Other
    Date Received
    March 16, 2007
    Date of Event
    May 31, 2005
    Report Date
    March 16, 2007
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THIS SITE THAT INCORRECT RADIOTHERAPY TREATMENT OCCURRED BECAUSE OF USER MISINTERPRETATION OF OUTPUT DATA PROVIDED BY GE ADVANTAGE SIM. THE SHIFT COORDINATES ARE GIVEN IN MILLIMETERS IN THE REPORT GENERATED BY ADVANTAGE SIM, BUT THEY ARE REQUIRED TO BE ENTERED IN CENTIMETERS IN THE NON-GE VARIAN ACCELERATORS. THE DIRECTION OF THE COORDINATES MAY HAVE ALSO BEEN MISINTERPRETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AW * IYE GE MEDICAL SYSTEMS SCS ADVANTAGE SIM 6, MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other