BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16498386 · Received March 7, 2023

    Report

    Report Number
    3007774465-2023-00019
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    May 15, 2020
    Report Date
    March 7, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K200569
    Removal / Correction Number
    RES 85796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE DESIGN DEFECT HAS BEEN IDENTIFIED. IN THE ERROR OCCURS FOR A TREATMENT SESSION WHERE A THE GANTRY ANGLE WAS NOT AS INTENDED, I.E. THAT DIFFERED FROM THE PLANNED ANGE BY MISTAKE, THE INCORRECT DISPLAY WOULD HIDE THIS MISTAKE. THIS COULD LEAD TO CONTINUING THE TREATMENT FOR FOLLOWING FRACTIONS AS PLANNED, RATHER THAN ADJUSTING THE PLAN BASED ON THE INCORRECT DELIVERY. IF DECISIONS ABOUT THE REMAINING TREATMENT THAT SHOULD HAVE BEEN MADE DUE TO THE INCORRECT TREATENT ARE NOT MADE, THIS COULD LEAD LOCAL OVER-AND/OR UNDERDOSAGE.

    Description of Event or Problem · 0

    NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. RAYTREAT ONLY SHOWS A SINGLE COLUMN FOR GANTRY ANGLE IN THE LIST OF BEAM DELIVERY RESULTS. THE GANTRY ANGLE DISPLAYED IN THE FIRST ROW FOR EACH BEAM WILL ALWAYS BE THE PLANNED ANGLE, NOT THE DELIVERED ANGLE. IF THERE IS MORE THAN ONE BEAM RECORD, E.G. IF THE BEAM HAS BEEN STOPPED AND RESTARTED MULTIPLE TIMES DURING THE SESSION, THE GANTRY ANGLE USED FOR DELIVERY WILL BE DISPLAYED IN THE FOLLOWING ROWS. HOWEVER, WHEN ONLY A SINGLE BEAM RECORD IS RECEIVED FOR A SPECIFIC BEAM, THE INFORMATION ABOUT BOTH THE PLANNED AND DELIVERED BEAM IS MERGED INTO A SINGLE ROW, TO SAVE SPACE. THIS HIDES ANY DELIVERED GANTRY ANGLE AND INSTEAD ONLY SHOWS THE GANTRY ANGLE THAT WAS PLANNED IN RAYSTATION.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00019 (B)(4) RS RAYTREAT DELIVERED GANTRY ANGLE. NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. RAYTREAT ONLY SHOWS A SINGLE COLUMN FOR GANTRY ANGLE IN THE LIST OF BEAM DELIVERY RESULTS. THE GANTRY ANGLE DISPLAYED IN THE FIRST ROW FOR EACH BEAM WILL ALWAYS BE THE PLANNED ANGLE, NOT THE DELIVERED ANGLE. IF THERE IS MORE THAN ONE BEAM RECORD, E.G. IF THE BEAM HAS BEEN STOPPED AND RESTARTED MULTIPLE TIMES DURING THE SESSION, THE GANTRY ANGLE USED FOR DELIVERY WILL BE DISPLAYED IN THE FOLLOWING ROWS. HOWEVER, WHEN ONLY A SINGLE BEAM RECORD IS RECEIVED FOR A SPECIFIC BEAM, THE INFORMATION ABOUT BOTH THE PLANNED AND DELIVERED BEAM IS MERGED INTO A SINGLE ROW, TO SAVE SPACE. THIS HIDES ANY DELIVERED GANTRY ANGLE AND INSTEAD ONLY SHOWS THE GANTRY ANGLE THAT WAS PLANNED IN RAYSTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61464 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 8A, 8A SP1, 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown