BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM LUMINOS TF

    MDR report key: 3964861 · Received July 17, 2014

    Report

    Report Number
    2240869-2014-05362
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAA
    PMA / PMN Number
    K051602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS CHECKED BY A LOCAL SIEMENS ENGINEER WHO FOUND THAT THE SWIVEL HANGER FOR 3D CABLES HAD COME DOWN AND IT WAS HANGING BY THE CABLES. THE HANGERS WERE REINSTALLED AND THE SYSTEM WAS BROUGHT BACK TO SPECIFICATIONS. THIS REPORT WAS SUBMITTED (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EITHER A CORRUGATED HOSE OR A CABLE HOLDER ON THE AXIOM ARISTOS TF SYSTEM BECAME LOOSE AND FELL DOWN FROM THE CEILING ON THE OPERATORS HEAD. APPROXIMATE WEIGHT OF THE CORRUGATED HOSE HOLDER IS 0.42KG. THE OPERATOR SUFFERED FROM A CONCUSSION AND RECEIVED MEDICAL TREATMENT AT THE FACILITY. THE EXTENT OF TREATMENT IS UNKNOWN. THE OPERATOR WAS SUPPOSED TO RETURN FOR AN ADDITIONAL EXAMINATION TWO DAYS AFTER THE INJURY TO DETERMINE HER READINESS TO GO BACK TO WORK. NO OTHER INFORMATION WAS PROVIDED TO SIEMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420327 AXIOM LUMINOS TF SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INT. JAA SIEMENS MEDICAL SOLUTIONS USA, INC. 10093902 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other