BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2160356 · Received June 20, 2011

    Report

    Report Number
    1720753-2011-08306
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 20, 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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE IMAGE INTENSIFIER. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED ADN PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM MADE A CLICKING NOISE AND WOULD NOT MAKE AN EXPOSURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1