BEUDAMED
    FDA Adverse Event Other Summary report: N

    UROLOGY TABLE X-RAY SYSTEM

    MDR report key: 199655 · Received November 25, 1998

    Report

    Report Number
    1720753-1998-00016
    Event Type
    Other
    Date Received
    November 25, 1998
    Date of Event
    November 16, 1998
    Report Date
    November 23, 1998
    Manufacturer
    OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 11/16/98 IT WAS REPORTED TO OEC MEDICAL SYSTEMS, INC. THAT AN ACCIDENTAL RADIATION OCCURRENCE HAPPENED ON ON OEC MODEL UROVIEW 2600. AT THE END OF A PROCEDURE, AFTER THE PT HAD BEEN REMOVED FROM THE TABLE, THE FOOTSWITCH WAS INADVERTENTLY KICKED UNDER THE TABLE CAUSING UNINTENDED X-RAYS. THE SYSTEM PRODUCED X-RAYS FOR 24 MINUTES AS THE HOSP STAFF ASSUMED THE X-RAY ALARM WAS THE ANESTHESIA MACHINE. ONCE THE STAFF REALIZED THEIR ERROR, THE SYSTEM WAS SHUT DOWN. OEC FIELD SERVICE ENGINEER TESTED/INSPECTED THE SYSTEM AND DETERMINED THE SYSTEM TO BE OPERATING AT CURRENT SPECS. FSE RETRAINED THE STAFF ON THE ALARMS AND EMERGENCY STOP BUTTON. THE HOSPITAL 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 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other