BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFILLED HUMIDIFIER

    MDR report key: 440330 · Received January 30, 2003

    Report

    Report Number
    1423507-2003-00010
    Event Type
    Malfunction
    Date Received
    January 30, 2003
    Report Date
    January 30, 2003
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED A SHORTNESS OF BREATH AS A RESULT OF DESATURATION. PT MOVED TO ICU AND GIVEN NON-INVASIVE VENTILATION. PLACED ON BI-PAP VISLSON VENTILATORY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFILLED HUMIDIFIER HUMIDIFIER BTT CARDINAL HEALTH 2D0803 Y1S0921

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention