BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1930036 · Received December 2, 2010

    Report

    Report Number
    9680959-2010-00548
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    September 13, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO GE SERVICE WAS NEEDED. CUSTOMER RESTORED THE SYSTEM TO OPERATE AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RATIO OF THE RADIATION FIELD TO THE FIELD OF VISION OF THE AMPLIFIER WAS OUTSIDE THE NORMAL LEVELS. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1