BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1914995 · Received November 17, 2010

    Report

    Report Number
    9680959-2010-00498
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    February 11, 2009
    Report Date
    November 17, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ABLE TO CLEAR THE FAULT AND DID NOT DESIRE GE SERVICE. CUSTOMER REPORTED SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM WILL NOT PRODUCE IMAGES. NO PT 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