BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRO CT SYSTEM

    MDR report key: 4626433 · Received March 20, 2015

    Report

    Report Number
    3010151377-2015-00001
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    February 18, 2015
    Report Date
    March 20, 2015
    Manufacturer
    MOBIUS IMAGING LLC
    Product Code
    JAK
    PMA / PMN Number
    K131431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INVESTIGATION DETERMINED THAT THE OPERATOR WAS NOT AWARE OF THEIR SURROUNDINGS (HOW CLOSE THEY WERE AWAY FROM THE WALL) AND/OR AWARE OF THE NORMAL STOPPING DISTANCE FOR THE AIRO SYS; AND THEY WERE NOT OPERATING THE AIRO SYS IN A SAFE MANNER BY TRYING TO BACK-UP THE AIRO INTO A POSITION SO CLOSE TO A WALL. THE OPERATOR WAS TRYING TO POSITION THE AIRO (PENDANT SIDE) APPROXIMATELY 8" FROM A WALL, BUT THEY COULD NOT DO THAT SAFELY WITHOUT PLAYING THEMSELVES IN BETWEEN THE WALL AND THE SYS. THE STOPPING DISTANCE FOR THA AIRO IS DOCUMENTED IN THE OPERATOR'S MANUAL AS LESS THAN 1 METER; IT APPEARS THAT THE OPERATOR WAS NOT AWARE OF THIS AND DID NOT LET GO OF THE DRIVE BUTTON SOON ENOUGH AND THIS LED TO THE REPORTED INJURY. AT THIS TIME, ADD'L TRAINING WAS PERFORMED AT THIS CUSTOMER SITE BY (B)(4)(DEVICE DISTRIBUTOR). MOBIUS HAS ALSO REQUESTED THAT THE TRAINING MATERIALS BE UPDATED TO PROVIDE MORE DRIVING EDUCATION AND HANDS-ON EXPERIENCE PRIOR TO ALLOWING AN OPERATOR TO DRIVE THE AIRO SYS. AS A RESULT OF THE ADVERSE EVENT, A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA (B)(4)) HAS BEEN OPENED TO PERFORM FURTHER INVESTIGATION. ANY NEW INFO WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    WHILE POSITIONING THE AIRO SYSTEM FOR A CERVICAL PROCEDURE IN (B)(6) THE OPERATOR BROKE HER ARM IN THE PROCESS. IN ORDER TO POSITION THE AIRO SYS FOR CERVICAL PROCEDURE, THEY NEED TO DRIVE THE AIRO CLOSE TO THE WALL (WITH THE DISPLAY FACING THE WALL) THE END POSITION IS APPROXIMATELY 20CM. WHILE POSITIONING THE AIRO SYS, IN RESPECT TO THE LAMINAIR AIRFLOW, THE DRIVER GOT STUCK WITH HER ELBOW AND WRIST BETWEEN THE AIRO SYSTEM AND THE WALL. THE OPERATOR NEEDED SURGERY TO STABILIZE THE FRACTURE IN BOTH THE ULNA AND RADIUS. THEY HAD TO CLOSE ONE OPERATING ROOM BECAUSE OF THE PERSONNEL SHORTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191731 AIRO CT SYSTEM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK MOBIUS IMAGING LLC MOBICT-32

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention