BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE 900

    MDR report key: 1241673 · Received November 19, 2008

    Report

    Report Number
    9617766-2008-01426
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE CAMERA IS OBSOLETE THEREFORE IT COULDN'T BE ORDERED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAS A CCD CAMERA WITH AN IMAGER 22 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE 900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1