BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO

    MDR report key: 5938688 · Received September 9, 2016

    Report

    Report Number
    1937649-2016-00007
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    June 27, 2016
    Report Date
    October 21, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INVESTIGATION IS ON-GOING. ELEKTA ARE CONTINUING TO ATTEMPT TO REPRODUCE THE PROBLEM AND DETERMINE THE CAUSE OF THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN UNABLE TO REPRODUCE HOW THE 3D PLAN "BWK12" WAS CREATED, NOR CAN (B)(4) EXPLAIN THE DISCREPANCY BETWEEN THE RESULTS SHOWN IN THE 3D PLAN "BWK12" AND IN THE PLAN "DOSISKONTROLLE". WITH THE INFORMATION THAT HAS BEEN PROVIDED, THERE IS CURRENTLY NO FURTHER INVESTIGATION POSSIBLE TO EXPLAIN THE DIFFERENCE IN THESE RESULTS. GIVEN THE LACK OF ADDITIONAL INFORMATION AVAILABLE, (B)(4) IS UNABLE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    A DOSE DISCREPANCY BETWEEN TREATED PLAN AND CONTROL PLAN. A 3D PLAN "BWK12" SHOWS A DOSE OF 36 GY BUT THE PLAN "DOSISKONTROLLE" HOLDING THE SAME VALUES SHOWS A DOSE OF 50.11 GY. PATIENT HAS BEEN TREATED WITH BWK12. TREATMENT RAN FROM (B)(6) 2016. FROM INITIAL INVESTIGATIONS, ELEKTA CAN CONCLUDE THAT THE PATIENT RECEIVED A DOSE OF RADIATION (86.4 GY) THAT WILL LIKELY RESULT IN SERIOUS INJURY. ELEKTA HAS CONTACTED THE CUSTOMER TO DISCUSS THE AMOUNT OF RADIATION THE PATIENT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593114 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other