BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1080328 · Received July 24, 2008

    Report

    Report Number
    9680959-2008-00062
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP PERFORMED BEAM ALIGNMENT PROCEDURE. TESTED X-RAY BEAM ALIGNMENT NOW WITHIN MFR'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "MISALIGNMENT OF THE RADIATION FIELD AND IMAGE SHALL NOT EXCEED 3% OF THE SID FOR EITHER THE WIDTH OR LENGTH AND THE SUM SHALL NOT EXCEED 4% OF THE SID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1