BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2063050 · Received March 21, 2011

    Report

    Report Number
    9680959-2011-00792
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS IS BEING REPORTED AS A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IRIS FUNCTION ON THE COLLIMATOR WOULD NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1