BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 2250929 · Received September 2, 2011

    Report

    Report Number
    2250929
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    WESTERN MEDICA
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    INTUBATED PATIENT REQUIRED OXYGEN TO TRANSPORT FROM SURGERY TO ICU. HOSPITAL USES A PORTABLE O2 TANK WITH DIRECT CONNECTION FOR THE AMBU BAG OXYGEN TUBING. THE O2 TUBING COULD NOT BE ATTACHED TO THE TAPERED HOSE BARB. THE TUBING CONNECTOR COULD NOT BE PUSHED ONTO THE TAPERED HOSE BARB. STAFF TRIED A SECOND AMBU BAG AND SAME PROBLEM. STAFF THEN CUT THE CONNECTOR OFF THE AMBU BAG TUBING AND FORCED THE TUBING ONTO THE TAPERED HOSE BARB. THE TUBING LEAKED, BUT THEY DID TRANSPORT SUCCESSFULLY WITH NO APPARENT HARM TO PATIENT. THIS IS "NOT THE FIRST TIME" SURGERY AND RESPIRATORY THERAPY STAFF HAVE HAD THIS ISSUE. THE RESPIRATORY STAFF THOUGHT THE PROBLEM WAS WITH OUR MEDICAL AIR VENDOR AND ATTEMPTED TO GET RESOLUTION THROUGH THAT COMPANY TO NO AVAIL.======================MANUFACTURER RESPONSE FOR OXYGEN REGULATOR, OXYTOTE (PER SITE REPORTER)======================OXYTOTE MANUFACTURER HAS BEEN MADE AWARE AND IS BEGINNING INVESTIGATION AS OF (B)(4)11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYTOTE REGULATOR, OXYGEN CAN WESTERN MEDICA MTR-510 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *