BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2193201 · Received July 21, 2011

    Report

    Report Number
    1720753-2011-20255
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP WAS UNABLE TO REPRODUCE THE PROBLEM. THE REP CLEANED AND RESEATED ALL CONNECTORS AND A BOARD IN THE WORKSTATION AND THE C-ARM, CHECKED AND ADJUSTED THE VOLTAGE AND CLEANED AND REBUILT THE IMAGE DIRECTORY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S PICTURE ROTATION BUTTON WAS NOT FUNCTIONAL. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1