BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19228647 · Received May 2, 2024

    Report

    Report Number
    19228647
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 4, 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 ARRIVED ON WT6 FROM ED AT 1506 W/ ALARMING O2 TANK. ED TO FLOOR STATES YES FOR PSI >1000 BY RN [REDACTED NAME]: PATIENT QUICKLY TRANSFERRED OVER TO THE WALL O2 FOR SAFETY. NO INJURY NOTED. R: STAR MOMENT FOR O2 SAFETY. TANK WAS TAKEN OUT OF SERVICE AND TAGGED TO BE RETURNED TO GAS COMPANY VIA OUR GAS DISTRIBUTOR. THIS IS 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 GAUGE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402737 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown