BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT POSITIONING SYSTEM

    MDR report key: 6802480 · Received August 17, 2017

    Report

    Report Number
    3003900998-2017-00001
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    May 24, 2017
    Report Date
    July 19, 2017
    Manufacturer
    FORTE AUTOMATION SYSTEMS, INC
    Product Code
    JAI
    PMA / PMN Number
    K122413
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FORTE AUTOMATION INVESTIGATION RESULTS: COMMUNICATIONS BETWEEN THE PATIENT POSITIONING SYSTEM AND THE ACCURACY FILTER CAN PERIODICALLY FAIL. DURING THIS TIME THE PATIENT POSITIONING SYSTEM SHOULD NOT MOVE. IT WAS FOUND THAT FOR CERTAIN SOFTWARE VERSIONS THE PATIENT POSITIONING SYSTEM WILL MOVE TO AN UNCOMPENSATED POSITION THAT CAN BE OFF A FEW MILLIMETERS IN Z. FORTE AUTOMATION IS INVESTIGATING A CORRECTION FOR THESE ISSUES. ALL FURTHER INFORMATION WILL BE REPORTED UNDER 21 CFR 806.10. NO ADDITIONAL FOLLOW-UP TO THIS REPORT IS ANTICIPATED.

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS INFORMED FORTE AUTOMATION SYSTEMS ON JULY 19, 2017 OF A FINDING AT A CUSTOMER SITE DURING COMMISSIONING OF THE PROTON SYSTEM. THEY NOTED SPORADIC POSITION INACCURACY OF THE ROBOTIC TREATMENT TABLE DURING TESTS AT THE PSI GANTRY 3 ON (B)(6) 2017. THE TREATMENT TABLE WAS MOVED TO A 95-DEG YAW POSITION. THE TABLE MOTION WAS COMPLETED WITH THE PROTON THERAPY CONTROLLER [PTC] DISPLAYING ALL COORDINATES FOR THE INTENDED POSITION. HOWEVER, THE POSITION OF A LASER TRACKER TARGET WAS FOUND TO BE 14 MILLIMETERS OFF THE INTENDED POSITION (ISOCENTER). AFTER MOVING THE TABLE TO A DIFFERENT POSITION AND GOING BACK TO EXACTLY THE SAME 95-DEG POSITION, THE LASER TRACKER TARGET WAS FOUND AT ISOCENTER WITHIN THE EXPECTED TOLERANCES. VARIAN INVESTIGATION OF THE ISSUE WAS UNABLE TO IDENTIFY A PROBLEM WITH THE VARIAN PROTON THERAPY CONTROLLER AND QUESTIONED WHETHER THE PROBLEM WAS WITH THE FORTE AUTOMATION PATIENT POSITIONING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580255 PATIENT POSITIONING SYSTEM PATIENT POSITIONING SYSTEM JAI FORTE AUTOMATION SYSTEMS, INC 7755-11 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1