BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1070339 · Received July 9, 2008

    Report

    Report Number
    9617766-2008-01184
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR CODE DISPLAYED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, SYSTEM HAD AN ERROR MESSAGE DISPLAYED ON MAINFRAME WHICH REQUIRED REBOOTING OF SYSTEM TO COMPLETE THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY, AND 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 INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1