BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19132915 · Received April 18, 2024

    Report

    Report Number
    19132915
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 27, 2024
    Report Date
    March 28, 2024
    Manufacturer
    WESTERN/SCOTT FETZER COMPANY
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED FROM THE EMERGENCY DEPARTMENT TO PCU ON 6L NASAL CANNULA. WHEN TRANSFERRING THE PATIENT FROM THE STRETCHER TO THE BED IT WAS NOTED THAT THE O2 TANK WAS NOT TURNED ON. UPON ASSESSMENT PATIENTS O2 SATURATION WAS 84%. PATIENT NOW ON 6L NASAL CANNULA MAINTAINING GOAL SPO2. THE OXYTOTE DEVICES REQUIRE A TWO-STEP PROCESS TO TURN ON THE OXYGEN DELIVERY: 1) TURN ON THE OXYTOTE, AND 2) TURN ON THE OXYGEN TANK. THIS DESIGN POSES A RISK TO OUR PATIENTS. DESPITE EDUCATION, THIS RESULTS IN HALF OF THE OXYGEN FAILURES HAVE BEEN DUE TO USER ERROR. MANUFACTURER RESPONSE FOR OXYTOTE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606771 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY OXYTOTE ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other