BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC STENOSCOP

    MDR report key: 1070364 · Received July 9, 2008

    Report

    Report Number
    9617766-2008-01068
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THE HARD DRIVE WAS FULL. GE REP REMOVED OLD PT IMAGES. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM WILL NOT SAVE IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. STENOSCOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1