BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIX TOP

    MDR report key: 3429600 · Received October 21, 2013

    Report

    Report Number
    2240869-2013-08895
    Event Type
    Other
    Date Received
    October 21, 2013
    Date of Event
    September 5, 2013
    Report Date
    October 1, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZZ
    PMA / PMN Number
    K971452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR MANUAL FOR MULTIX TOP SYSTEM (AXB1-150.620.01.01.02) CONTAINS WARNINGS REGARDING COLLISION/CRUSHING ZONES. THIS REPORT WAS SUBMITTED OCTOBER 17, 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT WAS SITTING ON A STOOL AT THE END OF THE MULTIX TOP SYSTEM TABLE WITH HIS LEGS UNDER THE TABLE. THE TECHNOLOGIST DID NOT REALIZE THAT THE PT'S LEGS WERE UNDER THE X-RAY TABLE AND INITIATED DOWNWARD MOVEMENT OF THE TABLE. THE PT'S LEGS WERE CAUGHT UNDER THE TABLE FOR A FEW SECONDS BEFORE THE OPERATOR STOPPED THE DOWNWARD MOVEMENT AND RAISED THE TABLE. THE PT COMPLAINED OF THIGH AND KNEE PAIN. THE X-RAY IMAGES WERE TAKEN AT ANOTHER FACILITY BUT NO INJURIES WERE IDENTIFIED. THE PT WAS RELEASED BUT DUE TO PAIN HE IS NOW RECEIVING PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538350 MULTIX TOP IRADIOLOGIC TABLE IZZ SIEMENS MEDICAL SOLUTIONS USA, INC. 475517 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other