BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIHEART LO-FLO

    MDR report key: 3433179 · Received September 26, 2013

    Report

    Report Number
    2028807-2013-00003
    Event Type
    Other
    Date Received
    September 26, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 16, 2013
    Manufacturer
    WESTMED, INC.
    Product Code
    CAF
    PMA / PMN Number
    K943600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CONFERENCE CALL MEETING WAS HELD ON 09/19/2013 AT 8:45 PACIFIC TIME. (B)(6) RT MANAGER FROM THE HOSPITAL PARTICIPATED AND FROM WESTMED ATTENDED: (B)(4). (B)(6) ACKNOWLEDGED THAT THE WESTMED NEBULIZER THE HOSPITAL USED (UNIHEART) IS NOT DESIGNED TO BE USED IN THE CIRCUIT IT WAS USED (THE UNI-HEART HAS A 22MM PORT) AND IN ORDER TO USE IT THEY DECIDED TO MAKE AN ADAPTATION USING A "STEP DOWN" FITTING. THE HOSPITAL SHARED THAT THE STEP DOWN FITTING IS WHAT POPPED OFF THE CIRCUIT (NOT THE NEBULIZER WHICH REMAINED ATTACHED TO THE STEP DOWN FIXTURE). WESTMED MANUFACTURES AND MARKETS A NEBULIZER SPECIFICALLY DESIGNED FOR THE APPLICATION THEY NEED IN CIRCUITS.

    Description of Event or Problem · 1

    PATIENT IN SEVERE RESPIRATORY DISTRESS. PATIENT INTUBATED. PATIENT 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
    488237 UNIHEART LO-FLO NEBULIZER CAF WESTMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R