BEUDAMED
    FDA Adverse Event Summary report: N

    MOSAIQ

    MDR report key: 4889812 · Received July 3, 2015

    Report

    Report Number
    2950347-2015-00022
    Date Received
    July 3, 2015
    Date of Event
    May 29, 2015
    Report Date
    December 18, 2015
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE "FINAL ASSESSMENT RESULTS" DOCUMENT SUBMITTED IN FOLLOW-UP #1 ON 16TH DEC 2015 CONTAINED MISSING INFORMATION ABOUT RELEVANT USER PERMISSIONS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE FINAL INVESTIGATION RESULT IS PROVIDED IN THE ATTACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER CREATED AN IMRT PLAN WITH 25 FRACTIONS @ 200 CGY AND A TOTAL DOSE OF 5000 CGY AND 7 TREATMENT FIELDS (1 - 7). AFTER TWO FRACTIONS, USER DECIDED TO CHANGE THE FIELDS AND CREATED 7 NEW FIELDS. THE USER THEN EDITED THE REMAINING SESSIONS IN THE TREATMENT CALENDAR TO SCHEDULE THE NEW FIELDS; REMOVED THE REMAINING SESSIONS AND CREATED THE REMAINING SESSIONS AGAIN. USUALLY THE SYSTEM WOULD ONLY ADD THE REMAINING 23 SESSIONS WHEN THE USER IS SELECTING THE SAME PRESCRIPTION FOR THE CALENDAR; HOWEVER, 25 FRACTIONS WERE INSERTED AGAIN, WHICH THE USER DID NOT RECOGNIZED. THE FULL SESSION WAS ABLE TO BE DELIVERED AND THERE WAS NO DOSE OVERRIDE MESSAGE EVEN THOUGH THE TOTAL DOSE WAS REACHED. USER DID NOT RECOGNIZE THE PROBLEM UNTIL THE NEXT SESSION WHERE THE OVERRIDE MESSAGE DISPLAYED. BASED ON THE AVAILABLE INFORMATION, MISTREATMENT OCCURRED; HOWEVER, DID NOT RESULT IN SERIOUS INJURY. THE USER COMPENSATES THE EXTRA FRACTION TREATED BY REDUCING THE BOOST PLAN OF 5 FRACTIONS @ 200 CGY TO 4 FRACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER CREATED AN IMRT PLAN WITH 25 FRACTIONS @ 200 CGY AND A TOTAL DOSE OF 5000 CGY AND 7 TREATMENT FIELDS (1 - 7). AFTER TWO FRACTIONS, USER DECIDED TO CHANGE THE FIELDS AND CREATED 7 NEW FIELDS. THE USER THEN EDITED THE REMAINING SESSIONS IN THE TREATMENT CALENDAR TO SCHEDULE THE NEW FIELDS; REMOVED THE REMAINING SESSIONS AND CREATED THE REMAINING SESSIONS AGAIN. USUALLY THE SYSTEM WOULD ONLY ADD THE REMAINING 23 SESSIONS WHEN THE USER IS SELECTING THE SAME PRESCRIPTION FOR THE CALENDAR; HOWEVER, 25 FRACTIONS WERE INSERTED AGAIN, WHICH THE USER DID NOT RECOGNIZED. THE FULL SESSION WAS ABLE TO BE DELIVERED AND THERE WAS NO DOSE OVERRIDE MESSAGE EVEN THOUGH THE TOTAL DOSE WAS REACHED. USER DID NOT RECOGNIZE THE PROBLEM UNTIL THE NEXT SESSION WHERE THE OVERRIDE MESSAGE DISPLAYED. BASED ON THE AVAILABLE INFORMATION, MISTREATMENT OCCURRED; HOWEVER, DID NOT RESULT IN SERIOUS INJURY. THE USER COMPENSATES THE EXTRA FRACTION TREATED BY REDUCING THE BOOST PLAN OF 5 FRACTIONS @ 200 CGY TO 4 FRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433655 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1