BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRD OXYGEN BLENDER

    MDR report key: 34904 · Received July 23, 1996

    Report

    Report Number
    34904
    Event Type
    Injury
    Date Received
    July 23, 1996
    Date of Event
    July 12, 1996
    Report Date
    July 22, 1996
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    BZR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABG BLOOD GAS DRAWN ON 7/12/96 INDICATED ELEVATED PO2. ON INVESTIGATION OXYGEN BLENDER DIAL READ .21 WITH A FLOW OF 0.5 LPM. THE NASAL CANNULA WAS ANALYZED AND READ 40% OXYGEN. AN INVESTIGATION OF DEVICE ON 7/18/96 BY THE MFR SHOWED THIS HIGH FLOW RATE BLENDER TO BE ERRATIC IN PERFORMANCE WHEN USED TO DELIVER A LOW FLOW RATE. WEIGHT 819 GM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD OXYGEN BLENDER OXYGEN BLENDER BZR BIRD PRODUCTS CORP. 5100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY Required Intervention