BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW XCT

    MDR report key: 11050931 · Received December 21, 2020

    Report

    Report Number
    3015777306-2020-00020
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    December 9, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    KPS
    UDI-DI
    00453560462131
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE REPORTED WAS THE GANTRY ROTATED IN CCW (COUNTERCLOCKWISE) DIRECTION AT A FAST RATE OF SPEED. THIS EVENT OCCURRED DURING A SERVICE EVENT; THEREFORE, THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO HARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT AFTER COMPLETING A SENSOR UPGRADE ON THE SYSTEM, HE WAS PERFORMING A 90 COR (CENTER OF ROTATION) CALIBRATION FOR THE LEHR (LOW ENERGY HIGH RESOLUTION) COLLIMATORS WHEN THE GANTRY ROLL PERFORMED AN UNREQUESTED MOTION. THE GANTRY ROTATED IN A CCW DIRECTION QUICKLY UNTIL THE CABLE MANAGEMENT LIMIT SENSORS WERE TRIPPED AND THEN ALL SYSTEM MOTION WAS HALTED. THE FSE CALIBRATED THE GANTRY ROLL MOTION. THE FSE THEN POWER CLEARED THE SYSTEM AND PERFORMED AN AUTO CALIBRATION. THE FSE PRO-ACTIVELY REPLACED THE SERVO AMPLIFIER FOR THE GANTRY ROLL. THE ISSUE ONLY OCCURRED THE ONE TIME AND HAS NOT RE-OCCURRED. ALL OF THE AVAILABLE INFORMATION AND LOGFILES WERE SENT TO PHILIPS ENGINEERING WHICH CONCLUDED: THAT DURING COR 90 CALIBRATION, GANTRY REVERSE ROTATION (GRR) OCCURRED AND THEN HALTED WHEN MEETING THE LIMIT SWITCH. THE CAUSE OF THIS BEHAVIOR IS THAT THE SOFTWARE DOES NOT CORRECTLY HANDLE TWO CONDITIONS: MOTION REACHES ZERO VELOCITY BUT IT NOT WITHIN THE ALLOWABLE DISTANCE FROM THE PROGRAMMED END POSITION TO COMPLETE THE MOTION IN A SINGLE STEP. MOTION REACHES THE PROGRAMMED END POSITION, BUT THE MAGNITUDE OF THE VELOCITY IS GREATER THAN THE ALLOWABLE RANGE OF VALUES TO COMPLETE THE MOTION IN A SINGLE STEP. THE RESULT OF MISSING THE THRESHOLDS FOR STOPPING IS THAT THE MOTION REVERSES DIRECTION AND ACCELERATES UNTIL THE MOTION IS STOPPED BY EXTERNAL MEANS (MOTION LIMIT SWITCH, ACTIVATION OF COLLISION SENSOR, OR ACTIVATION OF EMERGENCY STOP BUTTON). THE UNCOMMANDED GANTRY REVERSE ROTATION OCCURS VERY RARELY IN THE NORMAL USE CONDITIONS. FURTHERMORE, THE GANTRY REVERSE ROTATION IS NOT SPONTANEOUS, BUT A CONTINUATION OF THE COMMANDED MOTION BY THE USER AND IS DETECTABLE. THE SYSTEM HAS COLLISION SENSORS, HARDWARE AND SOFTWARE TRAVEL RANGE LIMITS AND EMERGENCY STOP CONTROLS WHICH CAN BE RELIED ON FOR THE USER TO STOP SYSTEM MOTIONS. PER THE INSTRUCTIONS FOR USE (IFU): BEFORE YOU START A STUDY, MAKE SURE THAT THE EQUIPMENT CAN PROCEED THROUGH ITS FULL RANGE OF INTENDED MOTIONS WITHOUT COMING INTO CONTACT WITH THE PATIENT OR OBJECTS. THE EMERGENCY STOP BUTTONS ACTIVATE QUICKLY TO STOP DETECTOR AND GANTRY MOTIONS. MAKE SURE THAT YOU ARE FAMILIAR WITH THE LOCATION OF THE EMERGENCY STOP BUTTONS, AND DO NOT HESITATE TO USE THEM. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THE GANTRY ROTATED IN CCW DIRECTION AT A FAST RATE OF SPEED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THE GANTRY ROTATED IN CCW DIRECTION AT A FAST RATE OF SPEED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508636 BRIGHTVIEW XCT SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW XCT 00453560462131

    Patients

    Seq Age Sex Outcome Treatment
    1