BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE GAUGE

    MDR report key: 19614260 · Received June 26, 2024

    Report

    Report Number
    19614260
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 28, 2024
    Manufacturer
    WESTERN/SCOTT FETZER COMPANY
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "TRANSPORTED VENTILATOR PATIENT TO CT-SCAN VENTILATOR ALARMING LOW O2 PRESSURE INTUBATED PT BEING TRANSPORTED TO CT-SCAN ON TRANSPORT VENT WITH PORTABLE TANK TRANSPORT WAS ALARMING LOW PRESSURE TANK PRESSURE WAS READING 1533PSI AND NO OXYGEN WAS FLOWING FROM TANK. PATIENT MANUALLY VENTILATED USING ANOTHER TANK. TANK REMOVED FROM SERVICE O2 COMPANY TO BE NOTIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678572 OXYTOTE GAUGE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY MNDR-600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown