BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1800081 · Received August 11, 2010

    Report

    Report Number
    1720753-2010-02446
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LEG EXTENSION IS HARD TO REMOVE. SYSTEM OPERATES AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1