BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2634081 · Received June 21, 2012

    Report

    Report Number
    2916710-2012-00022
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    WHEN IMPORTING THE PLAN WITH NDC, THE STOP ANGLE HAS THE EXTENDED FLAG SET ON THE DATA BASE, WHEREAS BY USING ECLIPSE IMPORT, THE EXTENDED FLAG FOR THE STOP ANGLE IS NOT SET. THE GANTRY ANGLES IN THE DICOM FILE GO FROM 179.9 TO 180.1 COUNTER CLOCKWISE. THIS MUST BE MAPPED TO 179.9 TO 180.1 ON THE DATA BASE (NO EXTENDED FLAGS SET). BUT AFTER IMPORT WITH NDC WE HAVE START ANGLE = 179.9 AND STOP 180.1E (EXTENDED!) ON THE DB. WHEN OPENING THE FIELD IN ECLIPSE YOU FIRST SEE THE CHECKMARK SET FOR THE EXTENDED FLAG OF THE STOP ANGLE. WHEN YOU TOGGLE THE ROTATION DIRECTION FROM CCW TO CW AND BACK TO CCW THE EXTENDED FLAG CHECKMARK DISAPPEARS (SO IT IS CORRECTED BY ECLIPSE). THE ANOMALY WAS IDENTIFIED INTERNALLY BY VARIAN ENGINEERING DURING TESTING. THIS DID NOT INVOLVE AN ACTUAL PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HIT

    Patients

    Seq Age Sex Outcome Treatment
    1