BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARISTOS FX

    MDR report key: 2232970 · Received July 22, 2011

    Report

    Report Number
    2240869-2011-00027
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    KPR
    PMA / PMN Number
    K013826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DETAILED INVESTIGATION OF THE SYSTEM IS NECESSARY TO DETERMINE THE ROOT CAUSE OF THE DESCRIBED ISSUE. FURTHER INFO WAS REQUESTED. SIEMENS LOCAL SERVICE ENGINEER, (B)(4), INSTRUCTED THE CUSTOMER ON HOW TO USE THE SYSTEM. IN AGREEMENT WITH THE CUSTOMER WARNING LABEL WITH SAFETY INSTRUCTIONS WILL BE POSTED IN THE EXAM ROOM. THE SYSTEM IS EQUIPPED WITH BOTH AN EMERGENCY SHUT-DOWN SWITCH AND TABLE STOP BUTTONS. THESE BUTTONS WILL HALT ALL SYSTEM MOVEMENTS UPON REQUEST AND ARE AVAILABLE TO THE OPERATOR IN CASES OF UNINTENDED DEVICE MOVEMENT. THE REPORTED EVENT APPEARS TO BE A SINGLE OCCURRENCE AND NO SIMILAR ISSUES HAVE REPORTED FROM THE FIELD. CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN EXAM, THE CUSTOMER SELECTED A PT AND AN ANATOMIC PROGRAM "KNEE FACE ON TABLE". THE PT WAS NOT YET POSITIONED ON THE TABLE, BUT WAS ON A PT BED NEAR THE TABLE TOP. WHEN THE USER GRABBED THE HAND CONTROLLER, WITHOUT PRESSING ANY BUTTONS, THE X-RAY TUBE AND DETECTOR SUDDENLY MOVED AT A VERY FAST SPEED AND DIDN'T STOP, EVEN AFTER THE USER RELEASED THE HAND CONTROLLER. THE X-RAY TUBE STOPPED VERY CLOSE TO THE PT'S HEAD. THE USER DID NOT PUSH THE EMERGENCY STOP BUTTON. THE CUSTOMER ADMITTED THAT THE OPERATOR WAS NOT LOOKING AT THE PT DURING THE SYSTEM MOVEMENTS. THERE IS NO INJURY INVOLVED IN THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARISTOS FX SYSTEM, X-RAY, STATIONARY KPR SIEMENS AG 10093864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other