BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1040741 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21359
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP REPLACED HIGH VOLTAGE CABLE. TESTED COLLIMATOR AND CAMERA FUNCTIONS. MACHINE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY RECEIVE COLLIMATOR TO LARGE ERRORS ON THE CARM DISPLAY. ALSO, THE SYSTEM WOULD BOOT UP WITH COLLIMATOR ERRORS AND THE COLLIMATOR WOULD NOT CLOSE. ALSO IRIS OPEN/CLOSES BY ITSELF. PATIENTS WERE INVOLVED BUT NOT INJURED.

    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