BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE AIRLIFE ADULT AMBU BAG

    MDR report key: 22555291 · Received July 21, 2025

    Report

    Report Number
    MW5173012
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 16, 2025
    Manufacturer
    AIRLIFE /VYAIRE MEDICAL, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AIRLIFE AMBU BAG MISSING DUCKBILL. THIS WAS ONLY NOTICE DURING RESUSCITATIVE EPISODE OF PT HAVING A LARYNGOSPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802037 VYAIRE AIRLIFE ADULT AMBU BAG VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD AIRLIFE /VYAIRE MEDICAL, INC. 2K8004 0000343006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown