BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE ADULT MANUAL RESUSCITATOR

    MDR report key: 2221174 · Received August 17, 2011

    Report

    Report Number
    2221174
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMBU BAG WITH ATTACHED MASK WAS USED ON PATIENT FOR RESPIRATORY SUPPORT. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTED A TEAR IN THE SEAL OF THE MASK. THE TEAR IN THE MASK PREVENTED ADMINISTRATION OF ADEQUATE BAG-MASK VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE ADULT MANUAL RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CARDINAL HEALTH 2K8017 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR