BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1992791 · Received February 4, 2011

    Report

    Report Number
    1720753-2011-00899
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE SYSTEM TO BE OPERATING AS INTENDED. THE EXTENDED FLUORO FUNCTION IS A FEATURE OF THE SYSTEM DURING AUTO FLUORO MODE WHICH ENABLES X-RAYS TO BE EMITTED FOR A SHORT PERIOD OF TIME AFTER A "TOE TAP" OR VERY SHORT DURATION FOOT PEDAL PRESS IN ORDER TO PROVIDE A HIGH QUALITY IMAGE. NO ACCIDENTAL RADIATION OCCURRENCE. GE REPRESENTATIVE TURNED OFF THE EXTENDED FLUORO FEATURE AT THE CUSTOMER'S REQUEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM CONTINUED TO FLUORO AFTER THE FOOT PEDAL WAS RELEASED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1