BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE 330 PROTON BEAM THERAPY SYSTEM

    MDR report key: 11975698 · Received June 10, 2021

    Report

    Report Number
    3013118233-2021-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 10, 2021
    Product Code
    LHN
    UDI-DI
    08615520004
    PMA / PMN Number
    K191521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BY WAY OF BACKGROUND, PRIOR TO DELIVERY OF PROTON RADIATION TREATMENT PLAN, A VSIM (OR "DRESS REHEARSAL") IS CONDUCTED THAT TESTS AND CONFIRMS THE PATIENT'S RESPECTIVE TREATMENT PLAN PRIOR TO THE DEPLOYMENT OF THE PROTON RADIATION. DURING VSIM, PATIENTS THAT REQUIRE IMMOBILIZATION USING ANESTHESIA ARE SUBJECTED TO ANESTHESIA, AND ALL CLINICAL WORKFLOWS (IMAGING, PATIENT POSITIONING, GANTRY (SCAN/DOSIMETRY NOZZLE) ANGLE) ARE PERFORMED.

    Description of Event or Problem · 0

    DURING A VIRTUAL SIMULATION (VSIM) TEST OF A (B)(6) YEAR OLD CANCER PATIENT THAT WAS UNDER GENERAL ANESTHESIA, THE MOTION CONTROL SYSTEM (MCS) (A SOFTWARE SYSTEM) DID NOT PERMIT AN OPERATOR'S COMMAND TO MOVE THE PATIENT POSITIONING ROBOT TO A NEW LOCATION. THE COMMAND TO THE MCS WAS MADE AFTER SUCCESSFUL RESOLUTION OF AN ALARM CONDITION ASSOCIATED WITH THE RADIANCE 330'S GANTRY CONTROL SYSTEM. THE PATIENT WAS SUSPENDED 51 INCHES OFF THE TREATMENT FLOOR AT THE TIME THE MCS WAS NOT RESPONDING TO OPERATOR COMMANDS. THE MCS WAS RESET BY REBOOTING THE COMPUTER ITS HOUSED ON, WHICH SUCCESSFULLY RESOLVED THE ISSUE ASSOCIATED WITH THE MCS. THE PATIENT WAS SUBSEQUENTLY MOVED TO A POSITION IN WHICH HE COULD BE TAKEN OFF THE PATIENT POSITIONING ROBOT AND SUCCESSFULLY TAKEN OFF ANESTHESIA. COMPLETION OF THE PATIENT'S VSIM WAS RESCHEDULED AND SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. PROTOM IS REPORTING THE MALFUNCTION OF THE MCS BECAUSE SHOULD A PATIENT UNDER GENERAL ANESTHESIA REQUIRE MEDICAL INTERVENTION TO ADDRESS A CLINICAL EVENT ASSOCIATED WITH THE ANESTHESIA, THE LOCATION OF THE PATIENT MAY POTENTIALLY IMPACT THE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877205 RADIANCE 330 PROTON BEAM THERAPY SYSTEM PROTON BEAM THERAPY SYSTEM LHN 330 08615520004

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR