BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 158464 · Received March 17, 1998

    Report

    Report Number
    1720753-1998-00005
    Event Type
    Malfunction
    Date Received
    March 17, 1998
    Date of Event
    March 14, 1998
    Report Date
    March 16, 1998
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON MARCH 16, 1998 IT WAS REPORTED TO OEC MEDICAL SYSTEMS, INC., THAT AN ACCIDENTAL RADIATION OCCURRENCE HAPPENED TO OEC MODEL 7600 COMPACT C-ARM. WHEN ATTEMPTING TO SETUP SYSTEM, THE RADIOLOGY TECHNOLOGIST TURNED THE SYSTEM POWER ON, AT WHICH TIME THE SYSTEM BEGAN PRODUCING UNINTENDED X-RAYS. THE RADIOLOGY TECHNOLOGIST THEN TURNED THE POWER OFF AND CALLED FOR SERVICE. FIELD SERVICE ENGINEER WAS ABLE TO DIAGNOSE THE MALFUNCTION TO OPERATOR ERROR. FSE FOUND THE ANNOTATION KEYBOARD PLUGGED INTO THE X-RAY ON SWITCH RECEPTACLE. FSE PLUGGED THE KEYBOARD INTO THE PROPER RECEPTACLE IN ACCORDANCE WITH OPERATOR INSTRUCTIONS FOUND IN THE OPERATORS MANUAL. HOSP REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY. OEC HAS OPENED A FORMAL FAILURE INVESTIGATION INTO THIS REPORTED ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other