BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8282450 · Received January 28, 2019

    Report

    Report Number
    3010151377-2017-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    May 18, 2017
    Report Date
    July 20, 2017
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    PMA / PMN Number
    K160126
    Removal / Correction Number
    3010151377-7/20/17-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ISSUE WITH THE MAIN-DRIVE MOTOR IS A RISK IN TRANSPORT MODE ONLY (WHILE DRIVING AND/OR TRANSPORTING THE SYSTEM). THERE ARE NO ADDITIONAL RISKS ASSOCIATED WITH THIS ISSUE IN SCAN MODE (DURING CLINICAL USE WITH A PATIENT). IF THE FAULT OCCURS, IT IS IMMEDIATELY IDENTIFIABLE BY THE OPERATOR. THERE HAVE BEEN NO INJURIES REPORTED (TO DATE) RELATED TO THIS ISSUE. SYSTEM BREAKING/STOPPING MECHANISMS ARE UNAFFECTED BY THE FAULT, AND THE OPERATOR CAN QUICKLY STOP ALL SYSTEM MOTION BY HITTING THE EMERGENCY STOP BUTTON. INVESTIGATION RESULTS: DUE TO AN ISSUE WITH THE CONFIGURATION SETTINGS OF THE MAIN-DRIVE MOTION CONTROLLER, IF A MAIN-DRIVE MOTOR HAS A BROKEN ENCODER OR SENSOR WIRE THERE IS A RISK OF UNINTENDED MOTION WHILE DRIVING OR TRANSPORTING THE AIRO SYSTEM. THE ROUTING OF THE MAIN-DRIVE MOTOR CABLE CAN CAUSE LONG-TERM REPEATED BENDING & FLEXING OF THE CABLE AND POSSIBLE BREAKAGE OF THE MOTOR WIRE(S) WHILE THE SYSTEM GOES INTO / OUT OF TRANSPORT MODE AND WHILE DRIVING OR TRANSPORTING THE SYSTEM. SINCE THE AIRO IS NOT CURRENTLY MONITORING FOR BROKEN MAIN-DRIVE MOTOR WIRES, IF A WIRE BREAKS THE MAIN-DRIVE MOTOR WOULD NOT GET THE CORRECT FEEDBACK AND THE MOTOR COULD BEHAVE UNPREDICTABLY. IF A MAIN-DRIVE MOTOR WIRE BREAKS, THE FOLLOWING BEHAVIORS COULD BE SEEN IN THE AIRO: WHEN PUSHING THE "FORWARD" OR "REVERSE" DRIVING BUTTONS WHILE IN TRANSPORT MODE, THE SYSTEM COULD RESPOND/MOVE IN THE OPPOSITE DIRECTION, WHEN DRIVING OR TRANSPORTING THE SYSTEM, THE DRIVING SPEED COULD CHANGE UNEXPECTEDLY (INCREASE UP TO 2 MPH OR DECREASE), WHEN STARTING TO DRIVE OR TRANSPORT THE SYSTEM, THE ACCELERATION RATE COULD CHANGE UNEXPECTEDLY (SYSTEM COULD LURCH FORWARD/BACK OR SLOW DOWN), WHILE DRIVING OR TRANSPORTING THE SYSTEM, THE MAIN-DRIVE MOTOR COULD STOP UNEXPECTEDLY. CORRECTIVE ACTIONS: AS A RESULT OF THIS MALFUNCTION, A CAPA HAS BEEN OPENED TO DOCUMENT INVESTIGATION AND CORRECTIVE ACTIONS. THE MOTION CONTROLLER FIRMWARE WILL BE UPDATED ON ALL SYSTEMS TO ENABLE BROKEN WIRE DETECTION IN THE MAIN DRIVE, WHICH WILL ELIMINATE THE RISK OF UNINTENDED MOTION. NOTE: COMPLAINT WAS INITIALLY CLASSIFIED AS NON-REPORTABLE. WHEN ADDITIONAL COMPLAINTS FROM DIFFERENT SITES WERE RECEIVED, ALL SIMILAR COMPLAINTS WERE REEXAMINED AND THIS CASE WAS THEN DETERMINED TO BE RELATED AND REPORTABLE.

    Description of Event or Problem · 1

    AIRO STUCK DURING TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75494 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