BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1173228 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26040
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CONNECTED THE UTILITY SUITE AND ADJUSTED THE SYSTEM IMAGING DEFAULTS. HE ADJ THE CONTRAST TO A NOMINAL VALUE OF 50 FOR FLUORO, ROADMAP, AND SUBTRACT. HE THEN VERIFIED THE SYSTEM FUNCTIONALITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TROUBLE WITH SUBTRACTIONS AND IMAGES GOING LIGHT. NO PATIENT INJURY WAS REPORTED.

    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