BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY TABLE X-RAY SYSTEM

    MDR report key: 127286 · Received October 14, 1997

    Report

    Report Number
    1720753-1997-00019
    Event Type
    Malfunction
    Date Received
    October 14, 1997
    Date of Event
    September 18, 1997
    Report Date
    September 30, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 19,97 IT WAS REPORTED TO OEC MEDICAL SYSTEMS INC., THAT AN ACCIDENTAL RADIATION OCCURRENCE HAPPENED TO OEC MODEL UROVIEW. HOSP REPORTED THAT WHILE CLEANING THE SYSTEM BETWEEN PROCEDURES, THE SYSTEM BEGAN PRODUCING X-RAYS. HOSP STAFF TURNED THE SYSTEM POWER OFF. OEC FIELD SERVICE ENGINEER WAS ABLE TO DIAGNOSE THE CAUSE OF THE MALFUNCTION. FSE REMOVED AND REPLACED PART, TESTED/INSPECTED AND RETURNED SYSTEM TO CURRENT SPECIFICATIONS. HOSP REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROLOGY TABLE X-RAY SYSTEM UROLOGY X-RAY SYSTEM JAA OEC MEDICAL SYSTEMS UROVIEW 2600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other