BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPHANIX

    MDR report key: 7577669 · Received June 7, 2018

    Report

    Report Number
    3006972752-2018-00001
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 4, 2018
    Manufacturer
    STEPHANIX RADIOLOGICAL SOLUTIONS
    Product Code
    JAA
    UDI-DI
    03664049000017
    PMA / PMN Number
    K102529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR R&D DEPARTMENT IS WORKING ON THIS ISSUE. WE THINK WE WILL BE ABLE TO PROPOSE A SOLUTION IN THE END OF NEXT MONTH (END OF (B)(6)).

    Description of Event or Problem · 1

    THE TABLE WAS IN VERTICAL POSITION, THE OPERATOR WANTED TO MOVE THE TABLE WITH JOYSTICK, BUT WHEN HE RELEASED THE COMMAND, THE TABLE KEPT MOVING UNTIL HE USED THE EMERGENCY STOP. THUS WE HAVE UNCOMMANDED TABLE MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422865 STEPHANIX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM JAA STEPHANIX RADIOLOGICAL SOLUTIONS D2RS 03664049000017

    Patients

    Seq Age Sex Outcome Treatment
    1