BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM ELITE

    MDR report key: 20165306 · Received September 7, 2024

    Report

    Report Number
    3004938766-2024-00025
    Event Type
    Malfunction
    Date Received
    September 7, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 6, 2024
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K202526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT TREATMENT DELAY WAS DUE TO GETTING A CRITICAL ERROR WHEN ATTEMPTING TO SCAN. AFTER THE SYSTEM WAS REBOOTED, IT IS FUNCTIONING NORMALLY. WE'VE IMPLEMENTED CORRECTIVE MEASURES TO MITIGATE RISKS AND PREVENT ERRORS. DAILY CALIBRATION AND QUALITY ASSURANCE TESTING ON THE SYSTEM WERE COMPLETED WITHOUT ANY ISSUES. NO PATIENT HARM OR OTHER ISSUES WERE REPORTED. NO ADDITIONAL PATIENT INFORMATION HAS BEEN RECEIVED; IF FURTHER INFORMATION HAS BEEN FOUND FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    WHEN ATTEMPTING TO SCAN THE PATIENT, TECHNICIANS ARE ENCOUNTERING A CRITICAL ERROR, RESULTING IN A DELAY IN THE PATIENT'S PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343124 OMNITOM ELITE COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown