BEUDAMED
    FDA Adverse Event Death Summary report: N

    8400STI

    MDR report key: 38590 · Received September 13, 1996

    Report

    Report Number
    2021710-1996-00001
    Event Type
    Death
    Date Received
    September 13, 1996
    Date of Event
    August 12, 1996
    Report Date
    August 13, 1996
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS TRACED TO THE PT CIRCUIT SET-UP BEING USED. THIS DEVICE DID NOT MALFUNCTION AND OPERATED PER SPECIFICATIONS WHEN CHECKED. THE PT CIRCUIT SET-UP USED FOR THIS PT INCLUDED A NUMBER OF FILTERS IN-LINE IN THE INSPIRATORY LEG OF THIS CIRCUIT. THESE FILTERS CAUSED ADDITIONAL RESISTANCE IN THE PT CIRCUIT. THE PT HAD TO OVERCOME THIS RESISTANCE IN ORDER TO DRAW AIR FROM THE VENTILATOR. WHEN THESE FILTERS WERE REMOVED FROM THE PT CIRCUIT, THE VENTILATOR OPERATED NORMALLY. THIS HOSPITAL WAS INSERVICED IN THE PROPER TECHNIQUE FOR PRESSURE AND FLOW TRIGGERING BY CO'S CLINICAL STAFF. SECTION F WAS ENTERED BY THE MFR BASED FON INFROMATION PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    UNIT WAS NOT ADEQUATELY SENSING THE INSPIRATORY EFFORT OF THIS PT. THIS PT'S WORK OF BREATHING WAS REPORTED TO BE MARKEDLY HIGH. THIS HOSP REPORTED A PROGRESSIVE DETERIORATION OF THIS PT. THIS PT CODED AND EXPIRED EARLY THE NEXT MORNING. THIS HOSP IS NOT SURE IF THE DEATH OF THIS PT IS RELATED TO THE INCREASE WORK OF BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8400STI VOLUME VENTILATOR CBK BIRD PRODUCTS CORP. 15404 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death HUDSON RCI KRATON VENTILATOR TUBING SET(690-40)| GIBECK BACTERIAL FILTER (#1910)| GIBECK HUMID-VENT FILTER RT30+ (#19992)