BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE OEC 9800

    MDR report key: 16784091 · Received April 21, 2023

    Report

    Report Number
    16784091
    Event Type
    Other
    Date Received
    April 21, 2023
    Date of Event
    January 31, 2007
    Report Date
    February 7, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IN FOR ENDOVASCULAR AAA STENT REPAIR. DURING MIDDLE OF CASE, C-ARM WENT INTO "OVERLOAD" ALARM. MACHINE WAS REBOOTED AND CASE PROCEEDED. PRIOR TO SHUTDOWN, THE DOCTOR HAD PARTIALLY PLACED A STENT INTO THE AORTA IN A "MAGNIFICATION MODE." WHEN C-ARM REBOOTED, IT CAME BACK UP IN "NORMAL" MODE. THE DOCTOR FINISHED THE STENT PLACEMENT IN "NORMAL" MODE NOT REALIZING C-ARM WAS NOT IN "MAGNIFICATION MODE." AN EXTRA STENT HAS TO BE OPENED TO REPAIR MALPOSITION SECONDARY TO C-ARM MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866784 GE OEC 9800 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE OEC MEDICAL SYSTEMS, INC. SERIES 9800 RE0975

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Male