BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 14186341 · Received April 22, 2022

    Report

    Report Number
    3004938766-2022-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 21, 2022
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K171183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED PERTAINING TO HARM OR INJURY TO THE PATIENT'S AT THIS TIME. BECAUSE THE USER HAD TO REPEAT THE PATIENT'S SCAN, IT WAS DETERMINED THAT THE ESTIMATED DOSE DELIVERED TO THE PATIENT WAS 0.00208 GY.CM. THIS IS WELL BELOW THE 1 GY THRESHOLD OF CONCERN. AT THIS TIME, THERE IS NO ROOT CAUSE ASSOCIATED TO A DEVICE COMPONENT. SERVICE CALLS WILL BE MONITORED GOING FORWARD FOR SIMILAR EVENTS AND ESCALATED IF REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WERE MULTIPLE FAULTS DURING SCANS AND AS A RESULT TWO PATIENTS REQUIRED RESCANNING. AS PER EMAIL CONVERSATION FROM THE FIELD SERVICE ENGINEER, ONE OF THE RESCANNED PATIENTS WAS AN INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714587 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown