BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARISTOS FX

    MDR report key: 1218860 · Received October 31, 2008

    Report

    Report Number
    2240869-2008-00023
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    SIEMENS AG
    Product Code
    IZO
    PMA / PMN Number
    K013826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SERIOUS INJURY RELATING TO THIS EVENT. THE RISK OF A DEATH OR SERIOUS INJURY IS EXTREMELY LOW, HOWEVER, WE REPORTED THIS MALFUNCTION IN THE ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE DETECTOR WAS IN THE TABLE MODE. THE DETECTOR DID NOT MAINTAIN THE HORIZONTAL POSITION, AND ANGLED DOWN TOWARD THE FLOOR. THE DETECTOR HIT THE TECHNOLOGIST ON THE RIGHT FOOT IN THE MIDDLE OF THE FOOT, CAUSING SORENESS OF THE FOOT. THE TECHNOLOGIST RETURNED TO WORK THE FOLLOWING DAY. THERE WAS A PT IN THE ROOM, BUT THE PT WAS NOT INVOLVED IN THIS EVENT. A SIEMENS SERVICE REP CHECKED THE UNIT, AND FOUND 3 OF THE 4 BOLTS THAT HOLD THE DETECTOR HORIZONTAL HAD THE HEADS BROKEN OFF. THE DETECTOR WAS REPLACED, AND THE ORIGINAL DETECTOR, ALONG WITH THE BROKEN BOLTS, WAS RETURNED TO THE FACTORY FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARISTOS FX SYSTEM, X-RAY, STATIONARY IZO SIEMENS AG 07414803

    Patients

    Seq Age Sex Outcome Treatment
    1