BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERETOM ELITE

    MDR report key: 10216318 · Received July 1, 2020

    Report

    Report Number
    3004938766-2020-00005
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    March 16, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ROOT CAUSE ANALYSIS BY OUR SERVICE TECHNICIAN, IT WAS DETERMINED VIA THE SYSTEM'S SCANNER LOG THAT THE 60V SUPPLY DROPPED DURING SCAN , WHICH CAUSED A TRANSLATE VELOCITY ERROR. IT WAS FOUND THAT LAPTOP WAS LOCKED UN-FINALIZED ON A REGISTERED FAILED STUDY. THE SERVICE ENGINEER THEN HAD TO END THE APPLICATION GUI AND REBOOT REMOTELY. THE ISSUE COULD ALSO HAVE BEEN CAUSED FROM THE CENTIPEDE STUDDERING WHICH RESETS THE 60V SUPPLY. AFTER FULL REBOOT THE SCANNER FUNCTIONED NORMALLY AND A TEST PROTOCOL WAS COMPLETED.

    Description of Event or Problem · 1

    SCAN FAILED DURING 1ST SCOUT ON A STROKE INFLICTED PATIENT. SYSTEM CONNECTION WAS GREY AND ICONS WERE LOCKED. PATIENT TRANSPORTED TO THE HOSPITAL FOR TREATMENT. THE SCANNER TRAVEL WAS NORMAL NO DEBRIS OR STUTTER AND THE INDICATORS WORKED BUT STAYED ON AFTER THE SCAN STOPPED. IT APPEARED TO BE LOSS OF COMMUNICATION AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682571 CERETOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL3000

    Patients

    Seq Age Sex Outcome Treatment
    1