BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8283370 · Received January 28, 2019

    Report

    Report Number
    3010151377-2017-00006
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    September 18, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    PMA / PMN Number
    K160126
    Removal / Correction Number
    3010151377-9/26/2017-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL FIX AND TIMING: THE ELMO MOTION CONTROLLER CONFIGURATION WAS MODIFIED TO REQUIRE HALL SENSORS TO AGREE WITH THE MOTOR ENCODER BEFORE ALLOWING MOTION. THIS ADDS A LEVEL OF REDUNDANCY BY REQUIRING 5 SIGNALS TO BE IN AGREEMENT. THIS CHANGE SHOULD ALLOW THE ELMO MOTION CONTROLLER TO DETECT AN ENCODER SIGNAL FAULT AND PUT THE SYSTEM IN A "SAFE" (NON-MOVING) STATE IF THE TILT DRIVE MOTOR ENCODER MALFUNCTIONS; EFFECTIVELY ELIMINATING THE CHANCE OF HARM OCCURRING FROM UNINTENDED MOTION OF THE GANTRY. MOBIUS IMAGING IS CURRENTLY WORKING ON THE UPDATE TO THE MOTION CONTROLLER CONFIGURATION SETTINGS. THE NEW VERSION OF THE TILT-DRIVE MOTION CONTROLLER CONFIGURATION SETTINGS SHOULD BE AVAILABLE FOR AIRO SYSTEMS BY THE END OF SEPTEMBER 2017. BRAINLAB WILL ACTIVELY CONTACT AFFECTED CUSTOMERS IMMEDIATELY TO SCHEDULE THE INSTALLATION OF THE UPDATE. MOBIUS IMAGING BELIEVES, DUE TO AN ISSUE WITH THE CONFIGURATION SETTINGS OF THE TILT-DRIVE MOTION CONTROLLER, IF A TILT-DRIVE MOTOR HAS AN INTERMITTENT CONNECTION OR BROKEN ENCODER OR SENSOR WIRE THERE IS A RISK OF UNINTENDED TILT MOTION OF GANTRY WHILE AIRO SYSTEM IS HOMING THE AXIS AT STARTUP OR PREPARING FOR A SCAN. SINCE THE AIRO IS NOT CURRENTLY MONITORING FOR INTERMITTENT CONNECTIONS OR BROKEN TILT-DRIVE MOTOR WIRES, IF A WIRE BREAKS OR THE SIGNAL BECOMES INTERMITTENT THE TILT-DRIVE MOTOR WOULD NOT GET THE CORRECT FEEDBACK AND THE MOTOR COULD BEHAVE UNPREDICTABLY. IF A TILT-DRIVE MOTOR WIRE BREAKS OR THE SIGNAL BECOMES INTERMITTENT THE FOLLOWING BEHAVIORS COULD BE SEEN IN THE AIRO: WHEN PUSHING THE GREEN BUTTON TO HOME/TILT THE GANTRY, THE GANTRY MAY TILT IN EITHER DIRECTION, AND AT A HIGHER THAN NORMAL SPEED. A TEST FIXTURE WAS ADDED TO A SYSTEM IN-HOUSE TO INTRODUCE AN INTERMITTENT FAILURE OF THE DIFFERENT MOTOR AND ENCODER WIRES, AND THE UNINTENDED MOTION OF THE GANTRY WAS REPLICATED. THE ELMO MOTION CONTROLLER CONFIGURATION WAS MODIFIED TO REQUIRE HALL SENSORS TO AGREE WITH THE MOTOR ENCODER BEFORE ALLOWING MOTION. THIS ADDS A LEVEL OF REDUNDANCY BY REQUIRING 5 SIGNALS TO BE IN AGREEMENT. THIS CHANGE SHOULD ALLOW THE ELMO MOTION CONTROLLER TO DETECT AN ENCODER SIGNAL FAULT AND PUT THE SYSTEM IN A "SAFE" (NON-MOVING) STATE IF THE TILT DRIVE MOTOR ENCODER MALFUNCTIONS. VERIFICATION TESTING WAS PERFORMED AND THE UPDATE WORKED AS INTENDED. THE FIRMWARE UPDATE MITIGATES THE RISKS ASSOCIATED WITH THIS FAILURE MODE. INVESTIGATION OF THE EXACT ROOT CAUSE IS STILL ON-GOING. THE CT TECHNICIAN/OPERATOR RUNNING THE SYSTEM WILL KNOW IF THE GANTRY TILTS, HOWEVER THE OPERATOR MAY NOT BE ABLE TO RESPOND (BY RELEASING GREEN BUTTON OR PRESSING THE EMERGENCY STOP BUTTON) IN TIME TO PREVENT HARM. THERE HAVE BEEN NO INJURIES REPORTED RELATED TO THIS ISSUE. CONCLUSION: THIS ISSUE WAS DETERMINED TO BE A CLASS I RECALL, REQUIRING IMMEDIATE NOTIFICATION TO ALL CUSTOMERS/USERS, FDA, AND ROW AUTHORITIES.

    Description of Event or Problem · 1

    RISK OF UNINTENDED TILT MOTION OF GANTRY WHILE AIRO SYSTEM IS HOMING THE AXIS AT STARTUP OR PREPARING FOR A SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73294 AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK MOBIUS IMAGING, LLC MOBICT-32

    Patients

    Seq Age Sex Outcome Treatment
    1