BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC STENOSCOP

    MDR report key: 2240636 · Received August 14, 2007

    Report

    Report Number
    9617766-2007-00150
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    July 24, 2007
    Report Date
    August 14, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED SEVERAL PCBS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    PRODUCT PROBLEM.

    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