BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220667 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01411
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 30, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CHECKED THE MONOBLOCK CONTROLLER BATTERY. HE RESEATED THE MONOBLOCK CONTROLLER, ERASED ALL NODES, PERFORMED A FILAMENT CALIBRATION AND COLLIMATOR CALIBRATION, AND REBUILT THE CALIBRATION FILES. THE SYSTEM FUNCTIONS NORMALLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON POWER UP, THE UNIT DISPLAYS CALIBRATIONS ERRORS FOR FILAMENT AND THE COLLIMATOR. NO INJURY TO PT 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