BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 8559955 · Received April 29, 2019

    Report

    Report Number
    3004938766-2019-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 19, 2019
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    UDI-DI
    10815411020335
    PMA / PMN Number
    K171183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OMNITOM CT SYSTEM ISSUE WAS REPRODUCED ON SITE BY SERVICE ENGINEER LEANING ON THE DRIVE BAR DURING CALIBRATION AT POWER UP, THE SYSTEM WAS RE-STARTED AND WORKED AS INTENDED. DAILY AND QA CALIBRATION SUCCESSFULLY PASSED DURING THE VISIT. UPON DIAGNOSIS, IF THE USER TOUCHED THE DRIVE BAR DURING CALIBRATION AT POWER UP, IT WOULD RESULT IN ERRONEOUS CALIBRATION, PRODUCING ERRATIC DRIVING BEHAVIOR FOR THE CT SYSTEM. OMNITOM USER MANUAL REV 3 PAGE 69 CAUTIONS THE USER TO NOT LEAN ON THE DRIVE BAR DURING CALIBRATION AT POWER UP. THE FOLLOWING CORRECTIVE ACTIONS ARE UNDERTAKEN BY OUR ENGINEERING TEAM TO PREVENT RECURRENCE OF THIS ISSUE: UPDATE THE SOFTWARE TO CHECK FOR PRIOR POSITION OF THE DRIVE BAR AND NOT PROCEED WITH CALIBRATION IF THE DRIVE BAR IS OUT OF RANGE, DISPLAY MESSAGE ON LCD TO NOT TOUCH DRIVE BAR DURING CALIBRATION, AND ADD LABEL TO CT SYSTEM TO NOT TOUCH THE DRIVE BAR DURING CALIBRATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE OMNITOM CT SYSTEM JUMPED FORWARD WHEN DRIVING. SEVERAL ATTEMPTS TO DRIVE THE SYSTEM FAILED. THE CT SYSTEM WAS LEFT ON AND LODGED IN THE CORNER OF THE STORAGE ROOM AS THE SYSTEM WAS DRIVING ERRATICALLY. NO PATIENTS OR STAFF WERE HARMED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355201 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000 10815411020335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other