BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19330421 · Received May 16, 2024

    Report

    Report Number
    19330421
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 22, 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 ON OXYGEN WAS BEING TRANSFERRED TO PICU. PATIENT NEEDED OXYGEN TANK FOR TRANSPORT. OXYGEN TANK READ IN THE GREEN AND AIR WAS COMING OUT UPON CONNECTING PATIENT. DURING TRANSPORT PATIENT STARTED DESATURATING AND DESPITE INCREASING OXYGEN DEMANDS PT CONTINUED TO DESAT WHEN OXYGEN TANK WAS REMOVED IT WAS STILL IN THE GREEN, BUT NO AIR WAS COMING OUT. OXYGEN TANK WAS BROUGHT TO THE FRONT AND SET AND LABELED TO NOT USE TANK WAS TAKEN OUT OF SERVICE AND TAGGED TO BE RETURNED TO GAS COMPANY THIS MAY BE RELATED TO A SAFETY NOTICE ISSUED BY WESTERN BUT THEIR GAUGES REMAIN FAULTY IN OUR FIELD OVER A YEAR LATER AND ARE TOLD THEY WILL NOT GET TO REPAIR THE ENTIRETY OUR FLEET FOR OVER A YEAR. MANUFACTURER RESPONSE FOR OXYGEN DELIVERY GAUGE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619114 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY MNDR-600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other