BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO S

    MDR report key: 2003225 · Received February 28, 2011

    Report

    Report Number
    2240869-2011-22805
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    MQB
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO SIEMENS EXPERTS AND LOCAL SERVICE, THE SYSTEM IS FUNCTIONING ACCORDING TO THE SPECIFICATIONS AND AS DESIGNED. THIS ISSUE APPEARS TO BE A RESULT OF AN OPERATOR ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WAS PRESENTED TO THE HOSPITAL FOR AN X-RAY. THE PATIENT WAS SITTING IN A CHAIR AT THE FOOT END OF THE YSIO SYSTEM TABLE WITH HER KNEES UNDER THE TABLE. ACCORDING TO THE ACTING DIRECTOR OF RADIOLOGY, (B)(6), THE FLOATING TABLE TOP WAS POSITIONED ALL THE WAY TO THE HEAD END SO THAT THE PATIENT'S LEGS WERE POSITIONED BENEATH THE MOVING PORTION OF THE TABLE. THE TECHNOLOGIST PUSHED THE KICK PLATE TO LOWER THE TABLE, AND LOWERED IT ONTO PATIENT'S LEGS, WHICH RESULTED IN THE PATIENT RECEIVING A BROKEN FEMUR. A FOLLOW-UP CALL TO THE ACTING DIRECTOR OF RADIOLOGY WAS MADE (B)(6), 2011, AND IT WAS CONFIRMED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YSIO S IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM MQB SIEMENS AG 10281163

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention