BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19237403 · Received May 3, 2024

    Report

    Report Number
    19237403
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    March 22, 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 TRANSPORTED TO RADIATION ONCOLOGY WITH NO OXYGEN RUNNING. PATIENT HAD TANK AND NASAL CANNULA. PATIENT WAITING IN HALL FOR TREATMENT AND NOT CONNECTED TO WALL O2. PATIENT BROUGHT INTO TREATMENT ROOM WHERE IT WAS FOUND THAT THE PTS O2 TANK WAS NOT ON. THE TANK WAS SET TO 2L, BUT THE SIDE VALVE WAS IN THE CLOSED POSITION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306293 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other