BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO RADICAL-7

    MDR report key: 9824032 · Received March 12, 2020

    Report

    Report Number
    9824032
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 10, 2020
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TERM C-SECTION WAS DELIVERED, PLACED ON RADIANT HEATED WARMER. INFANT RECEIVED POSITIVE PRESSURE VENTILATION (PPV) AND THE PULSE OX. WAS PLACED ON THE RIGHT WRIST PER NEONATAL RESUSCITATION (NRP) GUIDELINES. HOWEVER, THE MOSSIMO WAS ABLE TO READ THE HEARTRATE, BUT FAILED TO READ THE OXYGEN SATURATION. NURSE LEFT TO GRAB ANOTHER MOSSIMO LOCATED ON A NEARBY CART, BUT THAT MOSSIMO WAS ALSO ABLE TO READ THE HEART RATE BUT UNABLE TO READ THE OXYGEN SATURATION OF THE BABY. THIS NURSE AGAIN LEFT TO OBTAIN A YELLOW PORTABLE PULSE OXIMETER FROM A LABOR AND DELIVERY ROOM. THAT PULSE OXIMETER WAS FINALLY ABLE TO READ THE OXYGEN SATURATION OF THE BABY AT ~7 MINUTES OF AGE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285829 MASIMO RADICAL-7 OXIMETER DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1