BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONC MGT SYS

    MDR report key: 1944251 · Received December 6, 2010

    Report

    Report Number
    2916710-2010-00136
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFO SUGGESTS A MALFUNCTION IN THE DEVICE WHICH, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT USING ECLIPSE 8.9 STANDALONE AND EXPORTING A PLAN TO ARIA 8.8, THEY HAVE FOUND THAT IF THEY SELECT COMPATIBLE TO TREATMENT DURING THE EXPORT WIZARD, THE SETUP FIELDS CREATED IN ECLIPSE WILL CONVERT TO TREATMENT FIELDS. ONCE IMPORTED, THE SETUP FIELD ICONS CHANGE TO BLACK AND YELLOW AND HAVE EMPTY MU AND DOSE FIELDS IN THE REF POINT TAB OF RT CHART. IN ECLIPSE, THE SETUP FIELD ICON REMAINS BLUE AND GREY. IF WE DESELECT COMPATIBLE TO TREATMENT AND EXPORT, THE SETUP FIELD WILL IMPORT TO RT CHART AS A SETUP FIELD WITH NO CONVERSION. THERE WAS NO REPORT OF INJURY TO PT OR USER, AND PT DATA WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONC MGT SYS ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS ARIARO

    Patients

    Seq Age Sex Outcome Treatment
    1