BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 6722281 · Received July 18, 2017

    Report

    Report Number
    3004977335-2017-80559
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 12, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE REPORTED ISSUE WAS COMPLETED. NO SYSTEM FAILURE WAS DETERMINED. DURING ORTHO OGP ALL TABLE MOVEMENTS ARE BLOCKED AS PER SPECIFICATIONS EXCEPT PATIENT TRANSFER BUTTONS. THE ISSUE WAS REPRODUCED ON A TEST SYSTEM. WHEN ORTHO SEQUENCE IS SELECTED AND ORTHO POSITION IS REACHED (E.G. SYSTEM WAS READY FOR ORTHO SEQUENCE), ALL TABLE MOVEMENTS GET BLOCKED AT TABLE SIDE CONTROL AND REMOTE CONTROL CONSOLE, HOWEVER, TABLE MOVEMENTS REMAIN AVAILABLE WITH PATIENT TRANSFER BUTTONS. THIS BEHAVIOR CONTINUES UNTIL ORTHO SEQUENCE IS DESELECTED OR THE ORTHO POSITION IS COMPLETED; THEN ALL MOVEMENTS BECOME AVAILABLE AGAIN. DESCRIPTION OF THIS SYSTEM BEHAVIOR WILL BE ADDED TO THE USER MANUAL. THIS REPORT WAS SUBMITTED JULY 18, 2017.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6).

    Description of Event or Problem · 1

    DURING AN EXAMINATION ON THE AXIOM LUMINOS DRF THE PATIENT HAD A PANIC ATTACK. THE PATIENT WAS STANDING ON THE FOOTREST (72 CM AT HEIGHT) FOR ORTHO PROGRAM (GONIOMETRY). THE PATIENT STARTED PANICKING DUE TO THE HEIGHT OF THE DEVICE. THE OPERATOR INTERRUPTED THE EXAMINATION SEQUENCE AT THE REMOTE CONSOLE, RELEASED THE EXPOSURE SWITCH AND WENT TO THE PATIENT TO CALM HER DOWN. THE OPERATOR WAS STANDING NEXT TO THE PATIENT AWAY FROM THE CONSOLE UNABLE TO CHANGE THE OGP TO RELEASE THE MOVEMENT BLOCK ON THE SYSTEM. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT, HOWEVER, THERE MAY HAVE BEEN DANGER TO PATIENT FALLING OFF THE FOOTREST IF THE OPERATOR WOULD HAVE NOT COME OVER TO HELP. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500976 AXIOM LUMINOS DRF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10094200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other