BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19220005 · Received May 1, 2024

    Report

    Report Number
    19220005
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 27, 2024
    Report Date
    March 28, 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

    TANK FOUND ON FLOOR WITH A PSI READING OF 2524. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4) (THE DISTRIBUTOR OF OUR OXYGEN TANKS). WESTERN HAS ACKNOWLEDGED A FAILURE IN ITS GAUGES, BUT THEY CAN FAIL AT ANY TIME, OFTEN AT OUR SITES BEFORE/DURING/AFTER PATIENT CARE. THEY HAVE NOT BEEN ABLE TO SERVICE ALL OF OUR DEVICES AND SAY IT WILL TAKE MORE THAN A YEAR TO FINISH DOING SO. MANUFACTURER RESPONSE FOR OXYGEN DELIVERY GAUGE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993289 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other