BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARISTOS MX/VX

    MDR report key: 2585550 · Received May 18, 2012

    Report

    Report Number
    2240869-2012-00038
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    April 10, 2012
    Report Date
    May 17, 2012
    Manufacturer
    SIEMENS AG
    Product Code
    KPR
    PMA / PMN Number
    K013826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE OPERATOR MANUAL FOR THE AXIOM ARISTOS SYSTEM AXB4-111.620.02.01.02 SAFETY CHAPTER PAGE 21, "THE PT MUST ALWAYS PLACE HIS HANDS ONLY ON THE HAND GRIPS" PROVIDED FOR THIS SECURITY TO AVOID "ALL CRUSHING HAZARDS BETWEEN THE SYSTEM'S MOVING PARTS AND THEIR GUIDE OPENINGS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY TECH RELEASED TABLE BRAKES TO FLOAT THE TABLE. WHEN THE TABLE TOP STARTED TO MOVE TRANSVERSELY, THE PT QUICKLY GRABBED UNDER THE TABLE TOP FRAME AND CAUGHT HER FINGERS BETWEEN THE TABLE TOP AND BACK COVER OF THE TABLE. AS A RESULT, THE TIP OF THE PT'S RING FINGER WAS CUT OFF. THE DOCTOR PRESENT ON SITE REPORTEDLY ATTEMPTED TO REATTACH THE TIP OF THE FINGER, BUT WAS UNSUCCESSFUL. THE INJURED FINGER WAS BANDAGED AND THE PT WAS RELEASED FROM THE FACILITY. ACCORDING TO THE INFO RECEIVED FROM SIEMENS LOCAL SERVICE ENGINEER, (B)(6), THE CUSTOMER HAS NOT HEARD BACK FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARISTOS MX/VX SYSTEM X-RAY, STATIONARY KPR SIEMENS AG 05895003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other