BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8289012 · Received January 30, 2019

    Report

    Report Number
    3010151377-2018-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    February 16, 2018
    Report Date
    August 31, 2018
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    PMA / PMN Number
    K180393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CENTER ARTIFACTS AND BROAD RING ARTIFACTS WERE CONFIRMED. THE DMS WAS REPLACED AND THE SYSTEM PERFORMED AS INTENDED. 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-438 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
    82315 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