BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-RAY TUBE STAND

    MDR report key: 23520 · Received June 23, 1995

    Report

    Report Number
    23520
    Event Type
    Malfunction
    Date Received
    June 23, 1995
    Date of Event
    June 14, 1995
    Report Date
    June 23, 1995
    Manufacturer
    IMAGING & X-RAY INTL., INC.
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    X-RAY TUBE VERTICAL CHAIN FAILED ON NEWLY INSTALLED EQUIPMENT. THIS OR SOME OTHER CIRCUMSTANCE CAUSED THE TUBE TO LOWER QUICKLY TOWARD THE PT LYING ON THE TABLE. IT STOPPED INCHES AWAY FROM THE PT'S HEAD. THE X-RAY TECHNICIAN FEELS IT STOPPED DESCENDING BECAUSE SHE CAUGHT IT WITH HER WRISTS AS SHE GRABBED FOR IT. THE MFR FEELS IT WOULD HAVE STOPPED ANYWAY BECAUSE OF SAFETY FEATURES. THE INVESTIGATION IS CONTINUING. THE MFR IS FULLY COOPERATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-RAY TUBE STAND X-RAY TUBE STAND IYB IMAGING & X-RAY INTL., INC. CSTS-28

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other