BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2092823 · Received May 5, 2011

    Report

    Report Number
    9680959-2011-01183
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE IMAGE INTENSIFIER PARTS NEED TO BE REPLACED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADDITIONAL SVC INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S IMAGES WERE OUT OF FOCUS, AND THERE WAS LIQUID IN THE IMAGE INTENSIFIER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1