BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERINFLATION BAG SYSTEM

    MDR report key: 42865 · Received October 8, 1996

    Report

    Report Number
    MW4001641
    Event Type
    Malfunction
    Date Received
    October 8, 1996
    Date of Event
    October 1, 1996
    Report Date
    October 7, 1996
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT TIME OF DELIVERY, AFTER ONE PPV, THE BAG WOULD NOT INFLATE. WAS ABLE TO GIVE BLOW-BY OXYGEN ONLY. BABY DID NOT SUFFER ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERINFLATION BAG SYSTEM AMBU BAG BTM MARQUEST MEDICAL PRODUCTS, INC. 1663006 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other