BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1083874 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24030
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 16, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP EXAMINED THE SAVED IMAGE OF CONCERN AND FOUND NO ISSUE. THE SAVED IMAGE WAS A HIP REPLACEMENT AND THE CONCERN WAS THE FEMAR BONE WAS BOWED. CONFIRMED FEMAR WAS BOWED, SKIN LAYER WAS NOT BOWED, HIP IMPLANT WAS NOT BOWED. THE CHECKED "S" OF IMAGE INTENSIFIER, MEASURED 3MM OF "S" OVER 298MM FIELD OR 1.1%. ACCORDING TO SPECIFICATION DRAWING 901083 TYPICAL IS 5% OR 14MM OVER A 298MM FIELD. THIS SYSTEM MEASURED 1.1% WELL BELOW TYPICAL. SYSTEM IS OPERATING AS INTENDED AND WELL WITHIN LIMITS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMAGE QUALITY IS NOT THE SAME CENTER TO EDGES IN FIELD. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1