BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 10216320 · Received July 1, 2020

    Report

    Report Number
    3004938766-2020-00004
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    January 8, 2020
    Report Date
    June 30, 2020
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K171183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED TO THE FDA (B)(4) BY THE USER FACILITY TO THE FDA AND THE MANUFACTURER IS REPORTING THIS MDR WITH ADDITIONAL CONTEXT. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. UPON ROOT CAUSE ANALYSIS BY OUR SERVICE TECHNICIAN, IT WAS FOUND THAT THE TRANSPORT ASSEMBLY WAS STUCK IN THE MIDDLE OF ITS POSITIONING, AND THEREFORE IT COULD NOT GO TO TRANSPORT OR SCAN MODE. THE SERVICE ENGINEER REPLACED THE MOTOR AND THE CT SYSTEM IS BACK UP AND FULLY OPERATIONAL. THE CT SYSTEM PASSED THE DAILY CALIBRATION AND QA CHECK. NO RE-SCANNING WAS DONE FOR THE PATIENT.

    Description of Event or Problem · 1

    THE OMNITOM COMPUTED TOMOGRAPHY (CT) SYSTEM WILL NOT GO TO TRANSPORT / SCAN MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682899 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1