BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU BAG

    MDR report key: 745410 · Received July 10, 2006

    Report

    Report Number
    MW1039640
    Event Type
    Injury
    Date Received
    July 10, 2006
    Date of Event
    July 2, 2006
    Report Date
    July 10, 2006
    Manufacturer
    WESTMED, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT CHANGE BY MANUFACTURER, WESTMED, INC. WITHOUT NOTIFICATION. EFFECTIVE PRODUCT, MODEL #REF 7-9810, AMBU BAG. AMBU BAG ATTACHED SECURELY TO MASK WITH RED CAP. RED CAP PREVENTS AIR MOVEMENT BETWEEN BAG AND MASK. RED CAP SHOULD BE REMOVED FOR RESUSCITATION GEAR TO FUNCTION PROPERLY. STAFF SURPRISED BY PRESENCE OF RED CAP AND ONCE USED, NOTED IT SHOULD BE REMOVED PRIOR TO ATTACHMENT TO AMBU BAG. NOTIFIED MANUFACTURER OF OUR PT SAFETY CONCERN REGARDING THIS PRODUCT. THEY ARE WORKING ON PROVIDING A PERMANENT PREVENTATIVE RESPONSE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU BAG AMBU BAG BTM WESTMED, INC. REF 7-9810 63953

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability