BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERETOM ELITE

    MDR report key: 10216364 · Received July 1, 2020

    Report

    Report Number
    3004938766-2020-00009
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 30, 2020
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K172539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ROOT CAUSE ANALYSIS BY OUR SERVICE TECHNICIAN, IT WAS FOUND THAT THE DAILY CALIBRATION HAD FAILED AND THE CUSTOMER CLEARED THE MESSAGE AND SCANNED ANYWAYS. IT WAS SEEN THAT THE WORKSTATION SENT THE SCANNER THE NOTIFICATION BUT IMAGES WERE NOT IN THE BROWSER OR IN THE DATA FOLDER ON THE WORKSTATION. THE CUSTOMER RESENT THE STUDY FROM THE UI AND THE IMAGES WERE LOADED. A TICK CALIBRATION WAS COMPLETED AND THE RAW DATA WAS CHECKED. A DAILY CAL AND QA WAS COMPLETED AS WELL. DEVICE IS OPERATIONAL AND WAS RETURNED IN TO SERVICE. IT WAS FOUND THAT THE PATIENT RECEIVED THE FOLLOWING DOSE AMOUNT:: CTDIVOL (MGY) : 0.623, DLP (MGY.CM) : 31.16.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN THAT SHE STARTED A SCOUT SCAN ON AMBULANCE, BUT THE IMAGE DID NOT APPEAR. SHE TRIED AGAIN WITH THE SAME RESULT. PATIENT WAS TRANSFERRED TO THE HOSPITAL. CUSTOMER SAID THERE WAS A DAILY CALIBRATION FAILED MESSAGE, BUT SHE SCANNED ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684240 CERETOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL3000

    Patients

    Seq Age Sex Outcome Treatment
    1