BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 11043009 · Received December 19, 2020

    Report

    Report Number
    3004938766-2020-00015
    Event Type
    Malfunction
    Date Received
    December 19, 2020
    Date of Event
    May 21, 2020
    Report Date
    December 18, 2020
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K171183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED DURING AN ONSITE VISIT FROM A FIELD SERVICE ENGINEER (FSE), THE SYSTEM COMPLETED DAILY CALIBRATION, AND QA CHECK, FOLLOWED BY FOUR COMPLETED PATIENT SCANS WITH NO FAULT. ON THE FIFTH SCAN THE SYSTEM STOPPED, AS REPORTED BY CT TECHS. THE SYSTEM COMPLETED A SIXTH SCAN WITH NO FAULT, PASSED ANOTHER DAILY CALIBRATION, AND QA CHECK. PER COMMUNICATION RECEIVED FROM FSE, AN UPGRADE TO THE SOFTWARE VERSION CORRECTED THE ERROR THE DEVICE EXPERIENCED . IT WAS FOUND THAT EVEN THOUGH THE PATIENT EXPERIENCED AN ADDITIONAL SCAN, THE DOSE AMOUNT RECEIVED IS NOT CONSIDERED TO BE HARMFUL TO THE PATIENT.

    Description of Event or Problem · 1

    TECHNICIAN REPORTED THE SCANNER STOPPED INTERMITTENTLY IN THE MIDDLE OF A SCAN ON THREE DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507455 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1