BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1082623 · Received July 23, 2008

    Report

    Report Number
    9617766-2008-01222
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CLEARED THE NODES AND RELOADED THE NODE SOFTWARE. HE TESTED THE UNIT, IT BOOTED AND RAN NORMALLY. HE LATER REMOVED THE CAMERA COVER AND RESEATED THE PLUGS. THE REP TESTED THE SYSTEM, AND COULD NOT FIND THE IMAGING PROBLEMS. HE INSTALLED A NEW X-RAY ON LAMP ON THE WORKSTATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT DID NOT BOOT UP AND THE EXPOSURE LAMP NEEDS REPLACEMENT BECAUSE IT IS NOT WORKING. ALSO, THE SYSTEM WAS HAVING ISSUES WITH FLUORO. IT WAS GIVING STATIC IMAGES WHICH WERE NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1