BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8283468 · Received January 28, 2019

    Report

    Report Number
    3010151377-2018-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    March 20, 2017
    Report Date
    August 31, 2018
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    PMA / PMN Number
    K180393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BHC (BEAM HARDENING COEFFICIENT) AND DPO (DETECTOR POSITION OFFSET) VALUES WERE NOT ENTERED INTO THE SYSTEM CONFIGURATION, AS REQUIRED, AFTER THE PREVIOUS SERVICE OF THE DMS (MARCH 2017). BECAUSE THE CORRECT VALUES WERE NOT ENTERED INTO THE SYSTEM, THE CT IMAGES CONTAINED SOME FAINT CENTER ARTIFACTS AND BROAD RING ARTIFACTS. THE ARTIFACTS WERE IMMEDIATELY IDENTIFIABLE TO THE OPERATOR AS A SYSTEM ISSUE/MALFUNCTION RATHER THAN AN ACTUAL PATIENT ANATOMICAL ANOMALY. THIS CASE WAS INITIALLY DETERMINED TO BE NON-REPORTABLE BY THE MANUFACTURER BECAUSE THERE WAS NO REPORT OF INJURIES AND THE RISK OF HARM TO PATIENTS IF THIS WAS TO REOCCUR WAS DETERMINED TO BE REMOTE / NOT LIKELY TO CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THIS CASE IS BEING REPORTED AT THIS TIME BECAUSE DURING A FDA INSPECTION IN APRIL 2018 THIS CASE WAS SPECIFIED IN A FDA-483 AS BEING A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IMAGE ARTIFACT IDENTIFIED BY USER IN A PATIENT SCAN. NO ADDITIONAL SCANS OF THE PATIENT WERE REQUIRED; AND NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74973 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