BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIHEART LO-FLO

    MDR report key: 3341311 · Received August 16, 2013

    Report

    Report Number
    3341311
    Event Type
    Injury
    Date Received
    August 16, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 16, 2013
    Manufacturer
    WESTMED, INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SEVERE RESPIRATORY DISTRESS. PATIENT INTUBATED. PATIENT BECAME AGITATED AND VENTILATOR BEGAN BEEPING. PATIENT BECAME BRADYCARDIC. TOOK PATIENT OFF VENT TO BAG WITH AMBU BAG. A LARGE AMOUNT OF AIR ESCAPED FROM THE ET TUBE. PATIENT BECAME CALM. UPON EXAMINATION IT WAS NOTED THAT THE CONTINUOUS NEBULIZER HAD POPPED OFF CIRCUIT. IT WAS REPLACED ON TO THE EXHALATION VALVE AND THE PATIENT COULD NOT EXHALE. THE CONNECTIONS ALL APPEAR THE SAME AND ARE SAME SIZE. EVEN WHEN PLACED CORRECTLY THEY HAVE A TENDENCY TO POP OFF. STAFF WILL USE TAPE TO MAKE THE CONNECTION SNUG. THIS IS A WORK-AROUND AND NOT POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396239 UNIHEART LO-FLO NEBULIZER CAF WESTMED, INC. * *
    396240 AIRLIFE BREATHING CIRCUIT, VENTILATOR CAF WESTMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R UNIHEART LO-FLO CONTINUOUS NEBULIZER - WEST| MEDAIRLIFE OXYGEN TUBING BY AIR LIFE