BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION 500D

    MDR report key: 6804879 · Received August 18, 2017

    Report

    Report Number
    6804879
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 6, 2017
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RISK, RDE--- X-RAY FLUOROSCOPIC ROOM # 2 HAS A SAFETY ISSUE. IN ORDER TO GET ONE IMAGE THE TECHNOLOGIST HAS TO EXPOSE THE PATIENT TWICE. THIS DOES NOT FALL UNDER RADIATION SAFETY PROTOCOLS / GUIDELINES PUT FORTH BY HOSPITAL AND THE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583668 PRECISION 500D SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE MEDICAL SYSTEMS, INC. PRECISION 500D NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1