BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2193173 · Received July 22, 2011

    Report

    Report Number
    1720753-2011-20303
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 22, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SVC INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS WOULD NOT DISPLAY PT INFO REGARDING THE RADIATION DOES AT THE BOTTOM OF THE IMAGE. THE IMAGE NEEDS TO BE RESIZED AND RECONFIGURED TO INCLUDE THE NECESSARY PARAMETERS. 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