BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8241927 · Received January 11, 2019

    Report

    Report Number
    3010151377-2017-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    July 2, 2017
    Report Date
    August 31, 2017
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    UDI-DI
    00869346000200
    PMA / PMN Number
    K160126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIRO SYSTEM WAS INSPECTED BY THE PRODUCT DISTRIBUTOR ((B)(4)), AND THE SYSTEM DATA LOGS WERE REVIEWED BY THE DISTRIBUTOR AND MANUFACTURER (MOBIUS IMAGING). DURING THE INITIAL INSPECTION OF THE SYSTEM, THE GIMBAL ROTATION PROXIMITY SENSORS AND ONE OF THE ACTUATORS WERE FOUND DAMAGED. THE REVIEW OF THE SYSTEM LOGS SHOWED AN INTERMITTENT CHANGE IN THE ORIENTATION OF THE GIMBAL/SCAN DIRECTION DURING THE SCAN IN QUESTION. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT A MANUFACTURING ERROR LED TO THIS MALFUNCTION. THE GIMBAL ROTATION PROXIMITY SENSORS AND ACTUATORS WERE FOUND TO BE INCORRECTLY ASSEMBLED INTO THE GIMBAL, WHICH CAUSED ONE OF THE ACTUATORS TO COME IN CONTACT WITH, AND DAMAGE THE SENSORS, CAUSING THE INCORRECT SENSOR TO BECOME ACTIVATED INTERMITTENTLY. WHEN THE INCORRECT SENSOR BECAME ACTIVATED DURING THE RECONSTRUCTION OF THE SCAN, THE SYSTEM THOUGHT THAT THE SCAN WAS RUN IN THE OPPOSITE DIRECTION COMPARED TO THE ACTUAL SCAN DIRECTION, AND APPLIED THE INCORRECT DIRECTIONAL MARKERS (FOOT/HEAD AND RIGHT/LEFT) TO THE SCAN. THE AIRO SYSTEM WAS REPAIRED. THE FACTORY LOG FILES FROM ALL AIRO SYSTEMS WERE REVIEWED FOR EVIDENCE THAT OTHER SENSORS AND ACTUATORS WERE INCORRECTLY INSTALLED, AND NO EVIDENCE WAS FOUND TO INDICATE ANY OTHER AIRO SYSTEMS WERE ASSEMBLED INCORRECTLY. PREVENTATIVE ACTION(S): TO PREVENT THE INCORRECT ASSEMBLY OF THE GIMBAL ROTATION PROXIMITY SENSORS AND ACTUATORS FROM OCCURRING AGAIN, THE PROXIMITY SWITCH ACTUATORS AND THEIR RESPECTIVE MOUNTING PARTS WILL BE SEPARATED INTO SUB-ASSEMBLIES WITH DISCRETE ASSEMBLY PROCEDURES, WITH IDENTIFYING LABELS TO DISTINGUISH THE CORRECT MOUNTING POSITION; AND THE AIRO FINAL ASSEMBLY PROCEDURE WILL BE UPDATED TO CLEARLY SHOW THE CORRECT MOUNTING/INSTALLATION POSITION OF THE SENSORS AND ACTUATORS, AND HAVE A STEP IN THE PROCEDURE TO DOUBLE CHECK POSITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A DOUBLE-SIDED SI-SCREW-PLACEMENT WITH THE AIRO, THE ORIENTATION MARKERS ON THE IMAGE (FOOT/HEAD AND RIGHT/LEFT) WERE INCORRECT (REVERSED) FOR THE 2ND OF 3 SCANS. THE SURGEON WANTED TO OPTIMIZE ONE OF THE SCREWS, BUT BECAUSE OF THE WRONG ORIENTATION SHOWN ON IMAGE #2, THE SURGEON INITIALLY STARTED TO REMOVE THE INCORRECT SCREW. THEY REALIZED THE ERROR IMMEDIATELY AND PUT THE SCREW BACK IN THE SAME HOLE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35039 AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK MOBIUS IMAGING, LLC MOBICT-32 00869346000200

    Patients

    Seq Age Sex Outcome Treatment
    1