BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1040773 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21350
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP HAS NOT YET EVALUATED THIS SYSTEM. A FOLLOW-UP WILL BE FORTH-COMING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY WERE HAVING IMAGE QUALITY DIFFICULTIES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1