BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 962143 · Received December 12, 2007

    Report

    Report Number
    1720753-2007-08506
    Event Type
    Injury
    Date Received
    December 12, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 11, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. THREE ATTEMPTS HAVE BEEN MADE TO CONTACT CUSTOMER TO GET ADD'L INFO ON THE STAFF MEMBER THAT WAS INJURED. NO ADD'L INFO AT THIS TIME. A FOLLOW UP REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM C-ARM HAS A 'CATCH IN MOTION" AND AS A RESULT THE X-RAY TECHNOLOGIST "STRAINED HER BACK" WHILE PULLING THE SYSTEM BACK OR MOVING THE C-ARM. INITIAL ASSESSMENT BY THE CUSTOMER CONTACT INDICATED THAT MOTION SEEMED SMOOTH AND COULD NOT FIND A PROBLEM. NO ADD'L INFO AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other