BEUDAMED
    FDA Adverse Event Summary report: N

    YSIO

    MDR report key: 3052990 · Received April 11, 2013

    Report

    Report Number
    2240869-2013-02455
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    MQB
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS CHECKED BY SIEMENS LOCAL SERVICE. THE ENGINEER WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE OPERATOR MANUAL XPB7-010.620.01.02.02 PROVIDES CLEAR ADVICE AND WARNINGS REGARDING THE "CRUSHING HAZARDS" ON THE SYSTEM AND THE OBLIGATORY USE OF THE HAND GRIPS: "THE PATIENT AND OPERATING PERSONNEL MUST GRIP ONLY THE HANDLES WHICH ARE INTENDED FOR THE PROPER HANDLING OF THE EQUIPMENT OR POSITIONING OF THE PATIENT. WHERE THIS IS NOT POSSIBLE, ATTENTION MUST BE PAID TO POSSIBLE RISKS OF INJURY BY CRUSHING IN THE VICINITY OF MOVING PARTS. PAY SPECIAL ATTENTION TO THE RISKS OF CRUSHING FINGERS/HANDS BETWEEN MOVING PARTS AND THEIR GUIDE OPENINGS. BEFORE PERFORMING UNIT MOVEMENTS MAKE CERTAIN THAT THE PATIENTS DO NOT GRASP THE FRAME OF THE TABLETOP. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT GRASPED THE EDGE OF THE TABLE TOP WHEN THE YSIO SYSTEM MOVED TO POSITIONING. THE PATIENT'S FINGER GOT CAUGHT BETWEEN THE TABLE TOP AND THE BUCKY TRAY. THE INJURY TO THE PATIENT'S FINGER WAS VERY MINOR AND THE PATIENT DIDN'T SEEK ANY MEDICAL ATTENTION. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156428 YSIO IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM. MQB SIEMENS AG 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other