BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 11951648 · Received June 7, 2021

    Report

    Report Number
    3007774465-2021-00001
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 20, 2021
    Report Date
    February 21, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COUCH HAD A DEFAULT DENSITY THAT WAS CARBON FIBER OF 1.7 WHICH WAS NOT VALIDATED BEFORE CLINICAL USE. COUCH MODELS ARE PROVIDED BY RAYSEARCH, BUT EACH CLINIC NEED TO VALIDATE MODELS BEFORE CLINICAL USE. THIS IS INCLUDED IN TRAINING MODELS WHICH CAN BE DOWNLOADED FROM RAYCOMMUNITY.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2021-00001 (B)(6) COUCH DENSITY OVERRIDE. CLINIC HAS BEEN USING RAYSTATION 8B WITH A COUCH MODEL THAT THEY HAD NOT VALIDATED. THE DENSITY DEFINED IN THE COUCH MODEL DID NOT MATCH THAT OF THE ACTUAL DENSITY OF THE COUCH, LEADING TO INACCURATE DOSE CALCULATION. SEVERITY AND NUMBER OF PATIENTS AFFECTED ARE NOT KNOWN. WE HAVE REQUESTED MORE INFORMATION ABOUT DATES, NUMBER OF PATIENTS ETC FROM THE CLINIC. INCIDENT(S) CAUSED BY USE ERROR. THERE WAS NO MALFUNCTION IN RAYSTATION.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2021-00001 80009 RS COUCH DENSITY OVERRIDE. INCIDENT(S) CAUSED BY USE ERROR. THERE WAS NO MALFUNCTION IN RAYSTATION. CLINIC HAS BEEN USING RAYSTATION 8B WITH A COUCH MODEL THAT THEY HAD NOT VALIDATED. THE DENSITY DEFINED IN THE COUCH MODEL DID NOT MATCH THAT OF THE ACTUAL DENSITY OF THE COUCH, LEADING TO INACCURATE DOSE CALCULATION. SEVERITY AND NUMBER OF PATIENTS AFFECTED ARE NOT KNOWN. WE HAVE REQUESTED MORE INFORMATION ABOUT DATES, NUMBER OF PATIENTS ETC FROM THE CLINIC.

    Description of Event or Problem · 1

    CLINIC HAS BEEN USING RAYSTATION 8B WITH A COUCH MODEL THAT THEY HAD NOT VALIDATED. THE DENSITY DEFINED IN THE COUCH MODEL DID NOT MATCH THAT OF THE ACTUAL DENSITY OF THE COUCH, LEADING TO INACCURATE DOSE CALCULATION. SEVERITY AND NUMBER OF PATIENTS AFFECTED ARE NOT KNOWN. WE HAVE REQUESTED MORE INFORMATION ABOUT DATES, NUMBER OF PATIENTS ETC FROM THE CLINIC. INCIDENT(S) CAUSED BY USE ERROR. THERE WAS NO MALFUNCTION IN RAYSTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841340 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) 8B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other