BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENO 9000

    MDR report key: 1781145 · Received July 29, 2010

    Report

    Report Number
    9617766-2010-00411
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    May 31, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SCREEN IS BLANK WHEN TAKING IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENO 9000 STENOSCOP 9000 JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1