BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2241226 · Received August 18, 2011

    Report

    Report Number
    1720753-2011-21154
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 18, 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 SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PRODUCE AN IMAGE DURING FLUOROSCOPIC X-RAY. 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