BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 8800 FLEXVIEW

    MDR report key: 1781127 · Received July 29, 2010

    Report

    Report Number
    9617766-2010-00412
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    April 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPAIRED A MONITOR VIDEO CONNECTOR. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OCCASIONAL FAULT ON THE MONITORS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 8800 FLEXVIEW OEC MOBILE 8800 FLEXIVIEW JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1