BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19524141 · Received June 12, 2024

    Report

    Report Number
    19524141
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 13, 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

    GAUGE IS READING TOO HIGH (2404 PSI). DURING O2 ROUNDS THIS TANK WAS FOUND ON FLOOR 4.1. READING TO TOO HIGH ON TANK. SHOULD NOT BE OVER 2200. REMOVED TANK FROM SERVICE. THIS IS PART OF A PREVIOUSLY RECEIVED NOTICE OF GAUGE FAILURES FROM WESTERN, HANDLED BY OUR GAS DISTRIBUTOR AERO ALL GAS WHO RETURNS THE PRODUCT TO WESTERN FOR SERVICE/REPAIR. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).

    Description of Event or Problem · 0

    GAUGE IS READING TOO HIGH (2404 PSI). DURING O2 ROUNDS THIS TANK WAS FOUND ON FLOOR 4.1. READING TO TOO HIGH ON TANK. SHOULD NOT BE OVER 2200. REMOVED TANK FROM SERVICE. THIS IS PART OF A PREVIOUSLY RECEIVED NOTICE OF GAUGE FAILURES FROM WESTERN, HANDLED BY OUR GAS DISTRIBUTOR AERO ALL GAS WHO RETURNS THE PRODUCT TO WESTERN FOR SERVICE/REPAIR. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136629 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY MNDR-600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown