BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEONATAL

    MDR report key: 562904 · Received October 29, 2004

    Report

    Report Number
    MW1033703
    Event Type
    Injury
    Date Received
    October 29, 2004
    Date of Event
    October 15, 2004
    Report Date
    October 29, 2004
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF NEONATAL AMBU BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU NEONATAL AMBU BAG BTM AMBU INC. * 04218

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening