BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEUS OTS ASSEMBLY

    MDR report key: 561391 · Received January 26, 2004

    Report

    Report Number
    561391
    Event Type
    Other
    Date Received
    January 26, 2004
    Date of Event
    January 2, 2004
    Report Date
    January 26, 2004
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS BEING X-RAYED FOR POTENTIAL FRACTURE OF FACIAL BONES, WHEN A PIECE OF EQUIPMENT FELL FROM THE OVERHEAD TUBE AND LANDED NEXT TO THE PATIENT'S HEAD ON THE TABLE. THE PATIENT WAS UNHARMED. THE PIECE OF EQUIPMENT WAS REMOVED AND THE EXAM CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEUS OTS ASSEMBLY X-RAY MACHINE KPR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 229646 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *