BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERETOM ELITE

    MDR report key: 11043010 · Received December 19, 2020

    Report

    Report Number
    3004938766-2020-00016
    Event Type
    Malfunction
    Date Received
    December 19, 2020
    Date of Event
    August 27, 2020
    Report Date
    December 18, 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

    WHILE FIELD SERVICE ENGINEER WAS EXAMINING THE LAPTOP, ALL DIAGNOSTICS PASSED. HOWEVER, IT WAS NOTICED THAT THE LAPTOP HAD SEVERAL APPLICATIONS RUNNING, WHICH MAY HAVE CAUSED THE LAPTOP TO RUN SLOWLY. WHILE THE FIELD SERVICE ENGINEER WAS REVIEWING THE COMPUTER LOGS, IT WAS OBSERVED THAT THERE WAS A DISCONNECT WHEN THE SCOUT SCAN WAS RUNNING. THE CERETOM APPLICATION SEEM TO FUNCTION AFTER THE TECHNICIAN REVIEWED THE ISSUE. EVEN THOUGH THE PATIENT UNDERWENT TWO SCOUT SCANS, THE DOSE AMOUNT RECEIVED IS WELL BELOW THE DOSE THRESHOLD AND IS NOT CONSIDERED HARMFUL TO THE PATIENT.

    Description of Event or Problem · 1

    DURING THE INITIAL SCOUT SCAN OF A PATIENT, THE SCOUT IMAGE WAS NOT RECEIVED BY THE LAPTOP COMPUTER. THE TECHNICIAN COMPLETED A SECOND SCOUT SCAN AND RECEIVED THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507456 CERETOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM, PRODUCT CODE: JAK NEUROLOGICA CORPORATION NL3000

    Patients

    Seq Age Sex Outcome Treatment
    1