BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARISTOS FX

    MDR report key: 3940870 · Received July 8, 2014

    Report

    Report Number
    2240869-2014-05090
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. CX-RU US QT
    Product Code
    KPR
    PMA / PMN Number
    K013826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE PART WAS REQUESTED BY THE FACTORY FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CABLE HOLDER ON THE AXIOM ARISTOS FX FELL DOWN ON THE OPERATOR'S HEAD DURING AN EXAMINATION. THE CABLE HOLDER FELL DOWN FROM THE TRANSVERSE RAIL. THE OPERATOR SUFFERED A SMALL WOUND TO HIS HEAD. THE CUT WAS TREATED WITH MEDICINAL ALCOHOL AT THE FACILITY. THE OPERATOR CONTINUED WORKING AFTER THE INCIDENT. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395546 AXIOM ARISTOS FX SYSTEM, X-RAY, STATIONARY KPR SIEMENS MEDICAL SOLUTIONS USA, INC. CX-RU US QT 07414803 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other