BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERETOM ELITE

    MDR report key: 10216321 · Received July 1, 2020

    Report

    Report Number
    3004938766-2020-00006
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    April 27, 2020
    Report Date
    June 30, 2020
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K172539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ROOT CAUSE ANALYSIS BY OUR SERVICE TECHNICIAN, IT WAS FOUND THAT THE EXAM WAS NEVER CLOSED/FINALIZED, NOR WAS THE LAPTOP SHUT OFF. THERE WAS CONFUSION ABOUT HOW TO GET IMAGES FROM THE SOFTWARE IF THERE IS A WIRELESS DISCONNECT. ALL SCANS WERE FOUND. ADDITIONAL TRAINING FOR CUSTOMER TO NAVIGATE THE SOFTWARE. NO SIGNS OF PATIENT HARM OR DELAY.

    Description of Event or Problem · 1

    THE CUSTOMER RECENTLY HAD SOME ISSUES WITH NL3000, THE IMAGES WERE LOST AFTER THE SCAN HAD BEEN COMPLETED. THE SCANS WERE DONE, AND IMAGES WERE SCROLLED THROUGH AND REVIEWED. WHEN SCANNER WAS BROUGHT BACK TO THE CT AREA FOR TRANSMISSION TO PACS, THE IMAGES WERE UNABLE TO BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682900 CERETOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL3000

    Patients

    Seq Age Sex Outcome Treatment
    1