BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 109923 · Received July 29, 1997

    Report

    Report Number
    1720753-1997-00014
    Event Type
    Malfunction
    Date Received
    July 29, 1997
    Date of Event
    July 16, 1997
    Report Date
    July 28, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PHYSICIST TESTING OF THE SYSTEM, DOSE OUTPUT WAS HIGHER THAN NORMAL. OCE FIELD SERVICE ENGINEER WAS ABLE TO DIAGNOSE MALFUNCTION AND CONFIRM HIGHER THAN NORMAL DOSE OUTPUT. FSE REMOVED AND REPLACED FAILED PART, TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECS. 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 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other