BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1220645 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01385
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP FOUND A BURNED TRACE ON THE "90W-LOW POWER SUPPLY. ABOUT THIS POWER SUPPLY, IT WAS THE FIRST TIME REPLACEMENT ON THIS CUSTOMER (SYSTEM) FROM THE SYSTEM INSTALLATION. IT WAS CONSIDERED AGED DETERIORATION.

    Description of Event or Problem · 1

    THE OPERATION OR CATHETERIZATION WAS TERMINATED OR SUSPENDED DUE TO THE SYSTEM TROUBLE. SMOKE OCCURRED FOR A FEW SECONDS SUDDENLY JUST BEFORE THE END OF THE OPERATION. ABOUT THE PATIENT, IT WAS NOT NECESSARY FOR FURTHER EXPOSURE BECAUSE THE EXAMINATION HAD BEEN COMPLETED WHEN THIS PROBLEM OCCURRED.

    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