BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1191323 · Received October 9, 2008

    Report

    Report Number
    1720753-2008-20051
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. TIGHTENED PINS ON THE COLLIMATOR CABLE PLUG. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM INTERMITTENTLY DISPLAYED A COLLIMATOR ERROR MESSAGE (COLLIMATOR IRIS TOO LARGE). THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1