BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 4232448 · Received October 24, 2014

    Report

    Report Number
    2240869-2014-07895
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AXIOM LUMINOS DRF SYSTEM IS EQUIPPED WITH THE RED EMERGENCY STOP BUTTONS. PRESSING THESE BUTTONS WILL CAUSE THE SYSTEM DRIVES TO SHUT DOWN AND MOVEMENTS WILL BE STOPPED IMMEDIATELY. MOVEMENT CAN ONLY BE CONTINUED WHEN STOP IS CANCELED. IT WAS REPORTED THAT THE PROVIDED LOG FILES SHOW THAT IN THIS CASE NO EMERGENCY STOP BUTTONS WERE ACTIVATED BY THE OPERATOR. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED. CUSTOMER'S ADDRESS: (B)(6). THIS REPORT WAS SUBMITTED OCTOBER 22, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A BROKEN ANKLE WAS ON THE TABLE OF THE AXIOM LUMINOS DRF SYSTEM IN THE SUPINE POSITION WHEN THE TABLE SUDDENLY BEGAN TO TILT. ACCORDING TO THE PROVIDED INFORMATION, THE TILTING MOTION BEGAN WITHOUT THE OPERATOR INITIATING ANY SYSTEM MOVEMENT. THE MOVEMENT STOPPED WHEN THE TILT REACHED 90 DEGREES. THE OPERATOR HAD TO HOLD THE PATIENT TO PREVENT HIM FROM FALLING OFF THE TABLE UNTIL THE MOTION STOPPED. THERE HAVE BEEN NO INJURIES ATTRIBUTED TO THIS ISSUE. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677996 AXIOM LUMINOS DRF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY OWB SIEMENS MEDICAL SOLUTIONS USA, INC. 10094200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other