BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGIANCE (AIRLIFE)

    MDR report key: 415009 · Received September 3, 2002

    Report

    Report Number
    MW1026058
    Event Type
    Injury
    Date Received
    September 3, 2002
    Date of Event
    February 20, 2002
    Report Date
    March 5, 2002
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    CAH
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ALLEGIENCE HEPA FILTERS USED TO FILTER EXPIRATORY GASES ON VENTILATORS BECAME OCCLUDED DURING ROUTINE OPERATION. THE OCCLUSION PREVENTED THE PTS FROM EXHALING VIA THE EXPIRATORY SIDE OF THE SERVO 300 VENTILATOR. FORTUNATELY THE SAFETY VALVUE ON THE INSPIRATORY SIDE OPENED AND ALARMED. NO PTS WERE INJURED DURING THESE EVENTS, ALTHOUGH THEY HAD TO BE MANUALLY VENTILATED (BAGGED) UNTIL THE FILTER WAS CHANGED. THIS OCCURRED ON 5 PTS. HOSP HAS DISCONTINUED USE OF THE ALLEGIENCE HEPA FILTERS AND REPORTED THIS PROBLEM TO ALLEGIENCE HEALTHCARE INC. OCCLUDED FILTERS WERE SENT TO ALLEGIENCE CORP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE (AIRLIFE) HEPA FILTER CAH ALLEGIANCE HEALTHCARE CORP HEPA FILTER *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention 1) IN-LINE DRUG AEROSOL THERAPY VIA VENTILATOR| CIRCUIT. ALBUTEROL AND" PULMOZYME".