BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 326702 · Received April 11, 2001

    Report

    Report Number
    MW1021588
    Event Type
    Malfunction
    Date Received
    April 11, 2001
    Date of Event
    January 2, 2001
    Report Date
    January 24, 2001
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST WAS CALLED TO ASSIST WITH THIS PT WHOSE OXYGEN SATURATION HAD DECLINED TO 80% WITH OXYGEN AT 2L/M BY NASAL CANNULA. UPON ENTERING ROOM, RESPIRATORY THERAPIST DISCOVERED A LARGE CRACK ALONG SEAM ON OXYGEN BUBBLER. BUBBLER REPLACED. OXYGEN SATURATION INCREASED TO 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16640 * OXYGEN BUBBLER BTT AUTOMATIC LIQUID PACKAGING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other