BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19518558 · Received June 12, 2024

    Report

    Report Number
    19518558
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    April 17, 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

    CHARGE RN SETTLED PT IN ROOM WITH TRANSPORT. PT ON 4L NASAL CANNULA AND FOUND TRANSPORTABLE O2 TANK WAS NOT TURNED ON OR DELIVERING OXYGEN. PT SUSTAINED O2 SAT OF 86-88% WITHOUT O2 - DENIES ANY SOB OR DISCOMFORT. PRIMARY RN THEN CONNECTED PT TO WALL O2. O2 SAT IMPROVED TO 95%. NO OTHER CONCERNED AT THIS TIME. APSM NOTIFIED ON UNIT IN PERSON. THIS IS A USER ERROR BUT AN INHERENT RISK TO THIS TWO-STEP TURNING ON DESIGN WHICH HAS LED TO A LOT OF EVENTS WHERE OXYGEN IS NOT TURNED ON BUT THE GAUGE IS NOT DESIGNED TO ALERT FOR THAT. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188687 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY MNDR-600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown