BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.OX SP SENSOR

    MDR report key: 9621465 · Received January 23, 2020

    Report

    Report Number
    9621465
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    September 4, 2019
    Report Date
    December 2, 2019
    Manufacturer
    VIOPTIX, INC.
    Product Code
    MUD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STICKY ADHESIVE CAME APART FROM CORD AS WE WERE TRYING TO ATTACH IT TO THE PATIENT. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. A NEW PATCH WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88027 T.OX SP SENSOR OXIMETER, TISSUE SATURATION MUD VIOPTIX, INC. OXY-2-SPD-1-P5 D78320

    Patients

    Seq Age Sex Outcome Treatment
    1