BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2021661 · Received February 21, 2011

    Report

    Report Number
    9680959-2011-00479
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE SYSTEM STOPPED PRODUCING IMAGES DURING FLUORO. 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