BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOM ARISTOS MX/VX

    MDR report key: 2543091 · Received March 29, 2012

    Report

    Report Number
    2240869-2012-00030
    Event Type
    Other
    Date Received
    March 29, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 28, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPR
    PMA / PMN Number
    K013826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFORMATION THE TABLE TOP WAS CHECKED FOR UP/DOWN FUNCTION AND PROPER MOVEMENT/STOPS BY THE IN-HOUSE ENGINEERING GROUP. THE SYSTEM IS FUNCTIONING ACCORDING TO THE SPECIFICATIONS AND AS DESIGNED. THE UNINTENDED TABLE MOVEMENT WAS CAUSED BY THE PT'S MOTHER ACCIDENTLY HITTING THE FOOT SWITCH. THE OPERATOR MANUAL CONTAINS A WARNING CONCERNING "UNAUTHORIZED ACTUATION OF OPERATIONAL CONTROLS BY PTS" AND REQUESTS USERS TO "PAY ATTENTION TO THE PT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS PERFORMING A TABLE TOP EXAM ON A CHILD ON THE AXIOM ARISTOS MX/FX SYSTEM. THE CHILD WAS SITTING ON HIS MOTHER'S LAP DURING THE EXAMINATION. THE MOTHER WAS SITTING ON THE CHAIR THAT WAS PARTIALLY UNDER THE TABLE TOP. THE MOTHER'S FOOT ACCIDENTLY HIT THE TABLE TOP FOOT SWITCH CAUSING THE TABLE TOP TO LOWER ONTO HER SON'S LAP. NEITHER THE CHILD NOR THE MOTHER SUSTAINED ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARISTOS MX/VX SYSTEM, X-RAY, STATIONARY KPR SIEMENS MEDICAL SOLUTIONS USA, INC. 5895003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention