BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCLAREN PROTON THERAPY SYSTEM

    MDR report key: 10739687 · Received October 27, 2020

    Report

    Report Number
    3015178562-2020-00002
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 26, 2020
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    PMA / PMN Number
    K160063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CBCT BEGAN ROTATING AND ACQUIRED IMAGES FOR THE PATIENT ALIGNMENT PROCEDURE. DURING THE IMAGE ACQUISITION, THERE WAS AN INTERRUPTION OF THE HEARTBEAT THAT TRIGGERED THE SAFETY SYSTEM IN XPS. THIS RESULTED IN SETTING THE MOTORS TO ZERO TORQUE, AND WITHIN 1.6 SECONDS, ENGAGING THE BRAKE TO STOP THE ROTATION OF CBCT. UNFORTUNATELY, THE BRAKES DID NOT ENGAGE FAST ENOUGH TO STOP THE XPS FROM ROTATING. TO PREVENT THIS FROM HAPPENING AGAIN, THE ENGINEER HAS REDUCED THE DELAY TIME FROM 1600 MSEC TO 100 MSEC FOR THE BRAKING SYSTEM TO GET ACTIVATED AFTER THE SAFETY SYSTEM IS TRIGGERED. FURTHER TESTING HAS NOT SHOWN ANY FAILURE, AND THE ENGINEERING TEAM CONCLUDED THAT WITH THIS CHANGE, THE SYSTEM IS SAFE TO OPERATE.

    Description of Event or Problem · 1

    DURING PATIENT TREATMENT IN TREATMENT ROOM 1 THE IMAGING C-RING LOST TORQUE AROUND THE PATIENT ON THE TREATMENT COUCH, CAUSING THE X-RAY TUBE TO APPEAR TO COLLIDE WITH THE NOZZLE. THERE WERE NO ERROR WARNINGS, OR OTHER NOTIFICATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205331 MCLAREN PROTON THERAPY SYSTEM PROTON THERAPY SYSTEM LHN MCLAREN HEALTH CARE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR MCLAREN PROTON THERAPY SYSTEM