BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY TABLE X-RAY SYSTEM

    MDR report key: 171024 · Received June 1, 1998

    Report

    Report Number
    1720753-1998-00007
    Event Type
    Malfunction
    Date Received
    June 1, 1998
    Date of Event
    May 15, 1998
    Report Date
    May 28, 1998
    Manufacturer
    OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO OEC MEDICAL SYSTEMS, INC. ON 5/15/98 THAT AN UNCOMMANDED TABLE MOTION OCCURRED TO OEC MODEL UROVIEW 2000. DURING A PROCEDURE THE TABLE MOVED WITHOUT OPERATOR INPUT. THE HOSP STAFF UNPLUGGED THE TABLE HAND CONTROL SWITCH AND WAS ABLE TO FINISH THE PROCEDURE WITHOUT ANY FURTHER DELAYS. FIELD SERVICE ENGINEER WAS ABLE TO DIAGNOSE THE MALFUNCTION TO THE TABLE HAND CONTROL SWITCH. FIELD SERVICE ENGINEER ORDERED THE TABLE HAND CONTROL SWITCH, THE HOSP BIO-MEDICAL DEPT INSTALLED HAND SWITCH, TESTED/INSPECTED AND RETURNED THE SYSTEM TO CURRENT SPECS. 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 TABLE JAA OEC MEDICAL SYSTEMS UROVIEW 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other