BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOBILE C-ARM SERIES 9800

    MDR report key: 318919 · Received March 1, 2001

    Report

    Report Number
    1720753-2001-00001
    Event Type
    Other
    Date Received
    March 1, 2001
    Date of Event
    February 15, 2001
    Report Date
    March 1, 2001
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR HAD THE C-ARM POSITIONED WITH THE IMAGE INTENSIFIER, WITH A LASER AIMER ATTACHED, UNDER THE PT SUPPORT. THE DOCTOR AGGRESSIVELY RE-POSITIONED THE C-ARM TO THE LATERAL POSITION AND HIT THE EDGE OF THE TABLE WITH THE SIDE OF THE IMAGE INTENSIFIER KNOCKING THE GRID RETAINER, GRID AND LASER AIMER OFF AND ONTO THE FLOOR. NO PT INJURY WAS INVOLVED. THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8814 MOBILE C-ARM SERIES 9800 MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM JAA GE OEC MEDICAL SYSTEMS, INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other