BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 10273334 · Received July 14, 2020

    Report

    Report Number
    3007774465-2020-00003
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 16, 2020
    Report Date
    February 24, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH USABILITY COULD BE IMPROVED, RS FUNCTIONS AS DESIGNED AND THERE ARE INDICATIONS PRESENT TO ALERT THE USERS ABOUT MATERIAL OVERRIDES. ISSUING AN FSN WOULD NOT BE EFFECTIVE IN PREVENTING FURTHER INCIDENTS.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2020-00003 63063 RS DENSITY OVERRIDE. MATERIAL OVERRIDE INTENDED FOR CBCT WAS BY MISTAKE ALSO USED ON THE PLANNING IMAGE SET, LEADING TO THE ENTIRE PATIENT BEING MODELED AS WATER. THE INITIAL OVERRIDE WAS INTRODUCED BECAUSE OF DOSE TRACKING ON INCOMPLETE CBCT AND THAT STRUCTURE WAS BY ACCIDENT MAPPED ONTO THE NEW PLANNING CT AS WELL. THIS LED TO AN INCORRECT DOSE CALCULATION AND A 10% OVERDOSE OF THE RIBS. THE DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE CONSIDERED TO PREVENT SIMILAR USE ERRORS IN THE FUTURE.

    Description of Event or Problem · 1

    MATERIAL OVERRIDE INTENDED FOR CBCT WAS BY MISTAKE ALSO USED ON THE PLANNING IMAGE SET, LEADING TO THE ENTIRE PATIENT BEING MODELED AS WATER. THE INITIAL OVERRIDE WAS INTRODUCED BECAUSE OF DOSE TRACKING ON INCOMPLETE CBCT AND THAT STRUCTURE WAS BY ACCIDENT MAPPED ONTO THE NEW PLANNING CT AS WELL. THIS LEAD TO AN INCORRECT DOSE CALCULATION AND A 10% OVERDOSE OF THE RIBS. THE DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE CONSIDERED TO PREVENT SIMILAR USE ERRORS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736633 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 9A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other