BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1070805 · Received July 9, 2008

    Report

    Report Number
    1720753-2008-22841
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REP RELOADED SYSTEM SOFTWARE VERSION 9, ERASED PROGRAM FLASH MEMORY AND RE-DOWNLOADED CAL FILES USING UTILITY SUITE. IMAGE QUALITY TESTS AND CHECKS OUT OK. SYSTEM IS OK TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING FLUORO, SYSTEM WAS UNABLE TO GO THROUGH PT. THERE WAS POOR IMAGE QUALITY ON LEFT MONITOR DURING LIVE FLUORO. CASE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1