BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1843341 · Received September 22, 2010

    Report

    Report Number
    9680959-2010-00338
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    July 8, 2010
    Report Date
    September 22, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE B335 CIRCUIT BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING DISTORTED IMAGES, AND INTERMITTENTLY ONE MONITOR WILL BE BLACK, ONE WILL BE WHITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1