BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIANCE SATELLITE

    MDR report key: 3250780 · Received May 30, 2013

    Report

    Report Number
    3250780
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 30, 2013
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE MONITOR IN ONE OF THE OR ROOMS HAD A TEMPORARY GLITCH THAT CAUSED THE MONITOR TO DISPLAY THE PATIENT FROM ANOTHER ROOM. FORTUNATELY THERE WAS NO HARM TO PATIENT SINCE THE VITAL SIGNS FROM ANESTHESIA MONITORS WERE BEING OBSERVED AT ALL TIMES AND THERE WAS NO NOTICEABLE DISCREPANCY IN PATIENT CLINICALLY. THE PATIENT WAS PULLED UP ON THE NETKONNECT SYSTEM AND THE PUMP TEAM WAS LOOKING AT A DIFFERENT PATIENT THAN WHAT THEY THOUGHT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPEN HEART.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239255 RADIANCE SATELLITE MONITOR, PHYSIOLOGICAL MHX NIHON KOHDEN AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR NO OTHER THERAPIES