BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE FLUROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 112386 · Received August 5, 1997

    Report

    Report Number
    1720753-1997-00016
    Event Type
    Malfunction
    Date Received
    August 5, 1997
    Date of Event
    May 12, 1997
    Report Date
    August 5, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    OEC MEDICAL SYSTEM INC. RECEIVED A MEDWATCH FORM REGARDING A SYSTEM MALFUNCTION TO OEC MODEL 9000 SERIES C-ARM. ON MAY 14, 1997 IT WAS REPORTED TO OEC MEDICAL SYSTEMS THAT DURING A PROCEDURE THE SYSTEM BEGAN TO DISPLAY TRACK SEEK AND SECTOR MISSING ERRORS. SYSTEM WAS REMOVED AND BACKUP EQUIPMENT WAS USED TO FINISH PROCEDURE. FIELD SERVICE ENGINEER WAS ABLE TO DIAGNOSE THE MALFUNCTION. FSE REMOVED AND REPLACED 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 MOBILE FLUROSCOPIC IMAGE INTENSIFIED SYSTEM MOBILE C-ARM SERIES 9000 JAA OEC MEDICAL SYSTEMS 9000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other