BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16498411 · Received March 7, 2023

    Report

    Report Number
    3007774465-2023-00023
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    December 5, 2019
    Report Date
    March 3, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Removal / Correction Number
    RES 84705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AND THE ACTUAL OR POTENTIAL HEALTH HAZARD: A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. THE IMPLEMENTATION DOES NOT DISTINGUISH CORRECTLY BETWEEN SSD DEFINED AS SOURCE-TO-SKIN AND SSD DEFINED AS SOURCE-TO-SURFACE. IMMEDIATE AND/OR LONG-RANGE HEALTH CONSEQUENCES OF THE ACTUAL OR POTENTIAL HEALTH HAZARD: IN THE EVENT THAT THE GETSSD SCRIPTING FUNCTION IS INCLUDED IN A SCRIPT THAT IS SOMEHOW USED TO INFLUENCE CLINICAL DECISIONS, SSD INPUT DATA COULD BE MISLEADING.

    Description of Event or Problem · 0

    NO PATIENTS WERE AFFECTED. INTERNALLY FOUND BUG IN THE SCRIPTABLE METHOD BEAM.GETSSD. THE SCRIPT METHOD BEAM.GETSSD() CAN RETURN SOURCE-TO-SKIN DISTANCE INSTEAD OF THE EXPECTED SOURCE-TO-SURFACE DISTANCE, DEPENDING ON WHEN IT IS RUN. THE SAME ISSUE AFFECTS THE SSD DISPLAY IN DRR VIEWS IN THE REPORT AND IN EXPORTED DRRS. IN ADDITION, IN RAYSTATION 4.0, 4.5 AND 4.3 INVERSEARC, THE SSD IN THE REPORT DRR MAY SHOW OTHER VALUES THAN THE SOURCE-TO-SKIN OR SOURCE-TO-SURFACE DISTANCE. THE MAGNITUDE OF THE ERROR WILL DEPEND ON THE EXTENSION OF ANY BOLUS, FIXATION OR SUPPORT ROI IN THE BEAM CENTER PATH. THE ISSUE AFFECTS ELECTRON, PHOTON AND BNCT BEAMS ONLY, SINCE BEAM.GETSSD CANNOT BE USED FOR ION BEAMS AND SSD IS NOT DISPLAYED IN THE DRR FOR ION BEAMS. ONLY SCRIPTING, EXPORTED DRRS AND DRR IMAGES IN THE PLAN REPORT ARE AFFECTED. SSD IN THE PLAN REPORT IS CORRECT IN THE BEAM DATA SECTION, WHERE BOTH THE SOURCE-TO-SKIN AND SOURCE-TO-SURFACE VALUES ARE DISPLAYED. SSD IS ALSO CORRECT IN THE RAYSTATION GRAPHICAL USER INTERFACE (GUI). FOR SETUP BEAMS, THE DRRS SHOW CORRECT VALUE, BUT THE SCRIPT METHOD IS AFFECTED BY THE ISSUE.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00023 (B)(4) RS SSD INCONSISTENCY IN SCRIPTING METHOD GETSSD AND DRR IN REPORT. NO PATIENTS WERE AFFECTED. INTERNALLY FOUND BUG IN THE SCRIPTABLE METHOD BEAM.GETSSD(). THE SCRIPT METHOD BEAM.GETSSD() CAN RETURN SOURCE-TO-SKIN DISTANCE INSTEAD OF THE EXPECTED SOURCE-TO-SURFACE DISTANCE, DEPENDING ON WHEN IT IS RUN. THE SAME ISSUE AFFECTS THE SSD DISPLAY IN DRR VIEWS IN THE REPORT AND IN EXPORTED DRRS. IN ADDITION, IN RAYSTATION 4.0, 4.5 AND 4.3 INVERSEARC, THE SSD IN THE REPORT DRR MAY SHOW OTHER VALUES THAN THE SOURCE-TO-SKIN OR SOURCE-TO-SURFACE DISTANCE. THE MAGNITUDE OF THE ERROR WILL DEPEND ON THE EXTENSION OF ANY BOLUS, FIXATION OR SUPPORT ROI IN THE BEAM CENTER PATH. THE ISSUE AFFECTS ELECTRON, PHOTON AND BNCT BEAMS ONLY, SINCE BEAM.GETSSD() CANNOT BE USED FOR ION BEAMS AND SSD IS NOT DISPLAYED IN THE DRR FOR ION BEAMS. ONLY SCRIPTING, EXPORTED DRRS AND DRR IMAGES IN THE PLAN REPORT ARE AFFECTED. SSD IN THE PLAN REPORT IS CORRECT IN THE BEAM DATA SECTION, WHERE BOTH THE SOURCE-TO-SKIN AND SOURCE-TO-SURFACE VALUES ARE DISPLAYED. SSD IS ALSO CORRECT IN THE RAYSTATION GRAPHICAL USER INTERFACE (GUI). FOR SETUP BEAMS, THE DRRS SHOW CORRECT VALUE, BUT THE SCRIPT METHOD IS AFFECTED BY THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140729 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4-9A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other