BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYGEN BUBBLE HUMIDIFIER

    MDR report key: 12481 · Received March 31, 1994

    Report

    Report Number
    MW1001402
    Event Type
    Other
    Date Received
    March 31, 1994
    Date of Event
    March 19, 1994
    Report Date
    March 29, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    BTT
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW EPISODES OF BRADYCARDIA AND APNEA OCCURRED. OXYGEN SATS DECREASED. OXYGEN EQUIPMENT WAS CHANGED AND PT IMPROVED IMMEDIATELY. TWO OTHER BUBBLERS WERE IMMEDIATELY TESTED AND FOUND NOT TO DELIVER OXYGEN AT LOW FLOW RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN BUBBLE HUMIDIFIER OXYGEN BUBBLE HUMIDIFIER BTT PHARMASEAL DIV. BAXTER HEALTHCARE CORP. 2D 0801 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DAY Other NASAL CANNULA