BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY TABLE X-RAY SYSTEM

    MDR report key: 100274 · Received June 20, 1997

    Report

    Report Number
    1720753-1997-00013
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    May 23, 1997
    Report Date
    June 19, 1997
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JUNE 2, 1997 IT WAS REPORTED TO OEC MEDICAL SYSTEMS, INC. THAT AN ACCIDENTAL RADIATION OCCURRENCE OCCURRED TO OEC MEDICAL UROVIEW 2600. DURING A PROCEDURE THE SYSTEM APPEARED TO BE MAKING X-RAYS UNCOMMANDED. HOSP STAFF REMOVED THE X-RAY FOOTSWITCH FROM THE SYSTEM ALLOWING PROCEDURE TO BE FINISHED WITHOUT ANY FURTHER INCIDENTS. OEC FIELD SERVICE ENGINEER WAS UNABLE TO DUPLICATE REPORTED MALFUNCTION, HOWEVER FSE REMOVED AND REPLACED SUSPECTED FOOTSWITCH. HOSP REPORTED NO ADVERSE EVENT, DEATH, OR SERIOUS INJURY TO PT INVOLVED.

    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, INC. UROVIEW 2600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other