BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3955504 · Received June 12, 2014

    Report

    Report Number
    2950347-2014-00019
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF THE USER SELECTS THE FIELD FOR TREATMENT AND SCAN THE BARCODE TO CLEAR THE INTERLOCK, USER CAN THEN ENTER AUTOSETUP AND CHANGE THE X AND Y FIELD SIZE VALUES ON THE GANTRY/COLLIMATOR TAB. THE FIELD SIZE X AND FIELD SIZE Y CHECK BOXES ARE NOT GREYED OUT TO PREVENT CHANGES FROM BEING MADE. IN ADDITION, IF THE USER ENTERS AUTOSETUP PRIOR TO SCANNING THE BARCODE, THE EXPECTED BEHAVIOR IS FOR IT TO ALLOW THE FIELD SIZE TO BE CHANGED, BUT ON SCANNING THE BARCODE, A MESSAGE SHOULD BE DISPLAYED INDICATING 'THE APPLICATOR INFORMATION IN THE MAC ASSIGNS THE FIELD SIZE. YOU CANNOT CHANGE THE FIELD SIZE.' THIS MESSAGE IS NOT DISPLAYED. THERE WAS NO ACTUAL MISTREATMENT. THIS ISSUE WAS FOUND INTERNALLY, DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347483 MOSAIQ MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. MOSAIQ VERSION 2.50

    Patients

    Seq Age Sex Outcome Treatment
    1