BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.OX SP SENSOR

    MDR report key: 9882588 · Received March 26, 2020

    Report

    Report Number
    9882588
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 13, 2020
    Manufacturer
    VIOPTIX, INC.
    Product Code
    MUD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOT RESPONDING WHEN CORRECTLY PLACED ON TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345270 T.OX SP SENSOR OXIMETER, TISSUE SATURATION MUD VIOPTIX, INC. OXY-2-SPD-1

    Patients

    Seq Age Sex Outcome Treatment
    1