BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OCE 9600

    MDR report key: 853789 · Received May 22, 2007

    Report

    Report Number
    1720753-2007-01050
    Event Type
    Malfunction
    Date Received
    May 22, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 22, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. IT WAS DISCOVERED THAT THE CASE WAS PERFORMED WITH THE COLLIMATOR SHUTTERS CLOSED ALL THE WAY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM HAD A WHITE BAR IN THE CENTER OF THE MONITOR SCREEN DURING A CASE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OCE 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR