BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR, NEONATE LNCS

    MDR report key: 3879430 · Received May 29, 2014

    Report

    Report Number
    3879430
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 26, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DPZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PULSE OX PROBE FAILED TO REGISTER X TWO. HAPPENED WITH TWO DIFFERENT MONITORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316801 SENSOR, NEONATE LNCS OXIMETER, EAR DPZ MASIMO CORPORATION 1862 4A311

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY