BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1232566 · Received November 13, 2008

    Report

    Report Number
    1720753-2008-27994
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE GE SERVICE REP WAS ON SITE AND FOUND THAT THE SYSTEM GOES TO 120KV AT 6.3. HE OPENED THE SYSTEM UP AND FOUND THE SNUBBER FUSE WAS OPENED. HE CHECKED THE CANDLE STICKS AND THERE WERE NO SIGNS OF ARCING. HE ORDERED THE SNUBBER KITS AND WAS UNABLE TO RESOLVE THE CORRECT P/N FOR THE SNUBBER ALONE. HE ALSO ORDERED A X-RAY TUBE AND COVER. THE REP INSTALLED THE NEW SNUBBER AND TUBE AND AT FIRST EXPOSURE AT 40KV AND .5MA NO X-RAYS WERE EMITTED. HE CHECKED THE SNUBBER AND IT HAD BLOWN. HE ORDERED TANK AND MORE SNUBBERS. BEFORE INSTALLING TANK, THE REP REPLACED THE SNUBBER AND SLOWLY INCREASED KV AND MA. HE RAN THE FILAMENT CAL AND ALSO A 5MIN AT 120KV AND .2MA WITH NO PROBLEM FOUND IN OPERATION OR LOG FILES. THE OPERATIONAL CHECKOUT INCLUDED BOOT, FLUORO, IMAGE HANDLING, CONTROLS AND MECHANICALS. ALL WERE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM NOT MAKING XRAYS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1