BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19220003 · Received May 1, 2024

    Report

    Report Number
    19220003
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 3, 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

    [REDACTED DATE]: TANK FOUND ON FLOOR WITH A PSI READING OF 2238. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4). [REDACTED DATE]: NEW TANK CAME IN WITH A PSI READING OF 1675. PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4). THIS IS RELATED TO A SAFETY NOTICE ISSUED BY WESTERN BUT THEY 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 DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER). THIS IS RELATED TO A SAFETY NOTICE ISSUED BY WESTERN BUT THEY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993287 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown