BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1997796 · Received February 11, 2011

    Report

    Report Number
    9680959-2011-00370
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REBOOTED THE SYSTEM AND CLEARED THE FAULTS. SYSTEM OPERATES AS INTENDED. NO GE SERVICE WAS PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT PRODUCE AN IMAGE WITH THE FOOT PEDAL PRESSED, AND THE LAST IMAGE HOLD (LIH) FUNCTION WAS NOT WORKING. 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