BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 8605695 · Received May 13, 2019

    Report

    Report Number
    3004938766-2019-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 13, 2019
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    UDI-DI
    10815411020335
    PMA / PMN Number
    K171183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OMNITOM CT SYSTEM HAS SIGNIFICANT WEIGHT AND SIZE. WE ARE RELEASING A SERVICE BULLETIN FOR CUSTOMER THAT HIGHLIGHTS PEOPLE TO GET FAMILIARIZED WITH THE OMNITOM DRIVE SYSTEM AND TO REFRAIN FROM MANEUVERING/DRIVING THE SYSTEM IN SPACE RESTRICTED LOCATIONS.

    Description of Event or Problem · 1

    DURING NAVIGATION OF THE OMNITOM CT SYSTEM, TECHNOLOGIST WAS UNABLE TO GET THE OMNITOM TO TURN OR DO ANYTHING OTHER THAN GO BACKWARD. THIS RESULTED IN THE TECHNOLOGIST GETTING BACKED UP AGAINST A SINK. AFTER SEVERAL MINUTES THE TECHNOLOGIST WAS ABLE TO GET THE SYSTEM TO TURN HOWEVER THE CT SYSTEM KEPT STOPPING WHILE TRANSPORTING IT TO THE STORAGE LOCATION. NO PATIENTS WERE HARMED A RESULT OF THIS INCIDENT HOWEVER THE TECHNOLOGIST HAD SOME BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399130 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000 10815411020335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other