BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE OEC 9900 ELITE

    MDR report key: 787907 · Received November 17, 2006

    Report

    Report Number
    1720753-2006-00164
    Event Type
    Other
    Date Received
    November 17, 2006
    Date of Event
    October 19, 2006
    Report Date
    November 16, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY SERVICE PERSONNEL. NO ISSUES FOUND. DEVICE FUNCTIONS AS DESIGNED.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDERS FINGERS WERE PINCHED WHILE PERFORMING ORBITAL ROTATION OF THE C-ARM. THE INJURIES OCCURRED AT THE ORBITAL ROTATION PIVOT POINT. THE INJURIES OCCURRED BECAUSE THE USER GRABBED ON TO THE "C" IN ORDER TO ROTATE INSTEAD OF USING THE PROVIDED ROTATIONAL HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 ELITE FLOUROSCOPIC X RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *