BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19219955 · Received May 1, 2024

    Report

    Report Number
    19219955
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 8, 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

    NEW TANK CAME INTO THE RESPIRATORY DEPARTMENT WITH A PSI READING OF 1701. PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO AERO ALLGAS (OXYGEN DISTRIBUTOR).THESE GAUGES HAVE BEEN ACKNOWLEDGED BY THE MANUFACTURER WESTERN TO BE DEFECTIVE AT UNKNOWN RATE AND ARE REPAIRING VIA THE OXYGEN DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138249 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown