BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA EMR

    MDR report key: 3807210 · Received May 8, 2014

    Report

    Report Number
    MW5036062
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 25, 2014
    Manufacturer
    VARIAN
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS ARIA EMR DISPLAYS INCORRECT INFO ABOUT THE DELIVERY OF RADIATION THERAPY. ERROR OCCURS WHEN A ROUTINE EVENT OCCURS THAT MOMENTARILY INTERRUPTS TREATMENT. THE GANTRY ANGLE AND FIELD SIZE IS THEN REPORTED TO HAVE BEEN DIFFERENT THAN THE PLANNED POSITION WITHOUT ANY OTHER WARNING. THE ACTUAL TREATMENT WAS DELIVERED ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278307 ARIA EMR ARIA IYE VARIAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other