BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO CORPORATION

    MDR report key: 4192388 · Received October 14, 2014

    Report

    Report Number
    4192388
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 14, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    STAFF OBTAINED A PULSE OX MONITOR FROM THE CHARGING STATION WITH THE INTENT OF CONNECTING IT TO THE PATIENT TO MEASURE OXYGEN SATURATION. WHEN IT WAS CONNECTED TO THE PATIENT, THE MONITOR WOULD NOT TURN ON. ANOTHER DEVICE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650392 MASIMO CORPORATION OXIMETER DQA DRAEGER MEDICAL SYSTEMS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR