BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO

    MDR report key: 3760820 · Received April 9, 2014

    Report

    Report Number
    2240869-2014-02709
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS LOCAL SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND REPLACED THE END CAP. THE SYSTEM WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2014, THAT A PATIENT FELL UNCONSCIOUS IN THE EXAM ROOM AT WALLSTAND NEXT TO THE TABLE END OF THE YSIO SYSTEM. THE PT HIT THE END OF THE TABLE DURING THE FALL AND BROKE A PLASTIC CORNER PIECE. THE IMPACT RESULTED IN INJURY TO THE RIBS. THE PT ALSO RECEIVED LACERATIONS TO THE HEAD FROM THE EXPOSED TABLE CORNER AS HE FELL PAST IT. THE CUSTOMER CONFIRMED THAT THE PATIENT HAD FAINTED DUE TO HIS MEDICAL CONDITION AND NOT DUE TO THE EQUIPMENT. THE PT WAS TRANSPORTED BY AN AMBULANCE TO A DIFFERENT HOSPITAL FACILITY. THE PATIENT'S STATUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212978 YSIO STATIONARY X-RAY SYSTEM KPR SIEMENS MEDICAL SOLUTIONS USA, INC. 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other