BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 92197 · Received May 16, 1997

    Report

    Report Number
    1720753-1997-00008
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    April 25, 1997
    Report Date
    May 15, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 4/25/97 OEC MEDICAL SYSTEMS INC WAS NOTIFIED THAT AN OCE MODEL 9600 WAS PRODUCING HIGHER THAN NORMAL DOSE OUTPUT. DURING APPLICATIONS TRAINING OF HOSPITAL PERSONNEL SYSTEM INTERMITTENTALLY DISPLAYED ERROR MESSAGES WARNING OF THIS CONDITION. FIELD SERVICE ENGINEER DIAGNOSED SYSTEM AND CONFIRMED HIGHER THAN NORMAL DOSE OUTPUT. FSE REMOVED AND REPLACED FAILED PARTS, TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECIFICATIONS. HOSPITAL REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM MOBILE C-ARM SERIES 9600 JAA OEC MEDICAL SYSTEMS, INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other