BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3860801 · Received April 14, 2014

    Report

    Report Number
    1720753-2014-03248
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS BLURRED TO THE POINT OF EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227487 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1