BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3915215 · Received July 2, 2014

    Report

    Report Number
    3915215
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SPACELABS HEALTHCARE, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPACE LAB MONITOR WOULD NOT READ OXYGEN SATURATION LEVEL DESPITE NEW PROBE BEING APPLIED. THE CHANNEL WAS CHANGED OUT AND IMMEDIATELY WE WERE ABLE TO READ OXYGEN SATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385624 SPACELABS ULTRAVIEW SL COMMAND MODULE DETECTOR AND ALARM, ARRHYTHMIA DSI SPACELABS HEALTHCARE, INC. 91496-1BDHNRS *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA