BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASIMOSET

    MDR report key: 11723509 · Received April 23, 2021

    Report

    Report Number
    MW5100965
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 21, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    MONITOR WOULD NOT READ SPO2 - "FAULTY PROBE" ERROR. RED LIGHT ON PROBE WOULD NOT LIGHT UP DESPITE MULTIPLE NEW PROBES. SWITCHED O2 SAT CABLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614391 MASIMOSET OXIMETER DQA DRAEGER MEDICAL SYSTEMS, INC. 4085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention