BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 8287423 · Received January 29, 2019

    Report

    Report Number
    3010151377-2018-00004
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    November 8, 2017
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERMITTENT SIGNAL FROM ONE OF THE SYSTEM DAS BOARDS WAS CAUSING PIXELS IN THE CT IMAGE TO BECOME DARK, WHICH CAUSED AN IMAGE ARTIFACT IN TWO SLICES OF THE RECONSTRUCTION OF THE CT IMAGE. 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 (B)(4) AS BEING A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IMAGE ARTIFACT IDENTIFIED BY USER IN A POST-OP 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
    78897 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