BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODE BLUE IIZ RESUSCITATORS

    MDR report key: 520128 · Received March 26, 2004

    Report

    Report Number
    MW1031672
    Event Type
    Injury
    Date Received
    March 26, 2004
    Report Date
    March 26, 2004
    Manufacturer
    VITAL-SIGNS INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS BAGGED USING 100% OXYGEN WITH A CODE BLUE II RESUSCITATOR. OXYGEN SATURATION ON PT BEGAN TO DROP SIGNIFICANTLY AND PT EVENTUALLY WENT INTO RESPIRATORY ARREST. THE BAG WAS CHANGED OUT TO A NEW AMBU BAG AND OXYGEN SATURATION RETURNED TO AN ACCEPTABLE RANGE. DR REQUESTED THE AMBU-BAG IN QUESTION BE TESTED TO DETERMINE IF IT MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE BLUE IIZ RESUSCITATORS RESUSCITATOR, ADULT W/MASK BTM VITAL-SIGNS INC. * K 353

    Patients

    Seq Age Sex Outcome Treatment
    1 *