BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIX TOP

    MDR report key: 3843098 · Received September 11, 2013

    Report

    Report Number
    2240869-2013-07181
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    IZZ
    PMA / PMN Number
    K971452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR MANUAL FOR MULTIX TOP SYSTEM (AXB1-150.620.01.01.02) CONTAINS WARNINGS REGARDING COLLISION/CRUSHING ZONES. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PT WAS PRESENTED TO THE FACILITY FOR AN X-RAY OF A HAND. THE PT WAS SITTING IN A WHEELCHAIR ON THE SIDE OF THE MULTIX TOP SYSTEM TABLE WITH HIS LEGS UNDER THE TABLE. THE OPERATOR WAS BEHIND THE FOLDING SCREEN WHEN THE TABLE STARTED DESCENDING ON THE PT'S THIGHS WITHOUT ANY GIVEN COMMANDS. THE OPERATOR STOPPED THE DOWNWARD MOVEMENT BY PRESSING THE RED EMERGENCY STOP BUTTON. THE PT SUSTAINED NO INJURY AND DID NOT REQUIRE ANY MEDICAL ATTENTION. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457840 MULTIX TOP RADIOLOGIC TABLE IZZ SIEMENS AG 00475509

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR