BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1153645 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22278
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP RECALIBRATED THE SYSTEM MAG MODE TO BE WITHIN SPEC. SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BEAM WAS NOT RESTRICTED TO INPUT PHOPHOR + OR - 3% SID SINGLE DIRECTION AND + OR - 4% SID COMBINED DIRECTION IN MAG 2" MODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1