BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC STENOSCOPE

    MDR report key: 1613509 · Received February 16, 2010

    Report

    Report Number
    9617766-2010-00085
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    December 1, 2009
    Report Date
    February 15, 2010
    Manufacturer
    GE BE MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS. SYSTEM OPERATES AS INTENDED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT DISPLAY AN IMAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC STENOSCOPE SURGICAL NAVIGATION SYSTEM JAA GE BE MEDICAL SYSTEMS INC. STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1