BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1241683 · Received November 19, 2008

    Report

    Report Number
    9617766-2008-01431
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 16, 2006
    Report Date
    November 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE GE SERVICE REP TRIED REPLACING THE CCD INTERFACE BOARD, AND TRIED CHANGING THE VG3 USING R7 POT ON THE CD INTERFACE BOARD. THIS DID NOT WORK. HE THEN MANUALLY MOVED THE LEAD RING BLOCKER AT THE COLLIMATOR SIDE AND ALSO TRIED THE CAMERA SIDE. THIS FIX ALSO DID NOT WORK. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME FOR THE FIX ON THE SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE FIELD IS OUT OF TOLERANCE. THE RADIATED IMAGE WAS 20% LARGER THAN THE IMAGE ON THE MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1