BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 2853048 · Received August 20, 2012

    Report

    Report Number
    2240869-2012-06998
    Event Type
    Injury
    Date Received
    August 20, 2012
    Date of Event
    July 20, 2012
    Report Date
    July 25, 2012
    Manufacturer
    SIEMENS AG
    Product Code
    MQB
    PMA / PMN Number
    K062623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE OPERATOR MANUAL FOR AXIOM LUMINOS DRF SYSTEM AXD3-500.620.02.02.02 PAGE 27, OPERATOR HAS TO ENSURE THAT UNIT MOVEMENTS ARE RELEASED ONLY IF NEITHER PERSONS NOR OTHER PIECES OF EQUIPMENT CAN BE ENDANGERED BY THESE MOVEMENTS.

    Description of Event or Problem · 1

    A COLLISION OF THE MONITOR WITH THE X-RAY TUBE OCCURRED DURING AN EXAM WITH A PT ON THE TABLE. THE COLLISION CAUSED A BOLT INSIDE THE RIGHT COVER OF THE TUBE TO BE BROKEN AND THE COVER FELL ON THE PT. THE FALLING PART, WEIGHT APPROXIMATELY 0.5 KILOGRAM, CAUSED A SMALL CUT ON THE PT'S FOREHEAD. THE WOUND DID NOT REQUIRE ANY STITCHES. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM LUMINOS DRF IMAGE-INTENSIFIFED FLUOROSCOPIC X-RAY SYSTEM MQB SIEMENS AG 10094200

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other