BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1077758 · Received July 21, 2008

    Report

    Report Number
    1720753-2008-23080
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 30, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND IMAGES DISTORTED, BUT RESOLUTION OK. SYSTEM LOCATED IN UNFINISHED OR ROOM WITH ONGOING CONSTRUCTION WITH OPENED CEILING CAUSING IMAGE TO BE DISTORTED BY EMF. THE REP MOVED SYSTEM ACROSS THE ROOM AND FLUOROED, IMAGES LOOK BETTER. MOVED SYSTEM AGAIN TO A OPERTING OR DEPARTMENT AND IMAGES ARE NORMAL WITH NO DISTORTION. HE SAVED IMAGES TO SYSTEM AND VERIFIED SYSTEM IS OPERATING BY FLUOROING IN LOW AND HIGH TECHNIQUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POOR IMAGE QUALITY. 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