BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1844776 · Received September 23, 2010

    Report

    Report Number
    1720753-2010-03194
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE CALIBRATION FILES AND THE BATTERY ON THE GENERATOR INTERFACE BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING COLLIMATOR AND FILAMENT REGULATOR ERROR MESSAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1