BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 89390 · Received April 29, 1997

    Report

    Report Number
    1720753-1997-00007
    Event Type
    Malfunction
    Date Received
    April 29, 1997
    Date of Event
    April 23, 1997
    Report Date
    April 28, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON APRIL 25, 1997, CO RECEIVED INFO REGARDING AN ACCIDENTAL RADIATION OCCURRENCE TO CO MODEL SERIES 7600 C-ARM. DURING A PROCEDURE THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THE FOOTSWITCH WAS DIAGNOSED AS THE CAUSE FOR THE UNCOMMANDED X-RAYS. STAFF REMOVED FOOTSWITCH AND USED HAND SWITCH TO FINISH PROCEDURE. HOSPITAL REPORTED NO ADVERSE EVENT, OR SERIOUS INJURY TO PATIENT OR STAFF MEMBER INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM MOBILE C-ARM SERIES 7600 JAA OEC MEDICAL SYSTEMS, INC. 7600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other