BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMS/CARDYNE

    MDR report key: 478813 · Received August 13, 2003

    Report

    Report Number
    MW1029304
    Event Type
    Injury
    Date Received
    August 13, 2003
    Date of Event
    July 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    DISTRIBUTER - TRI-ANIM HEALTH SERVICES
    Product Code
    BTM
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS DECREASED SAO2 AT 60%. WAS BEING VENTILATED VIA AMBU BAG. SAT'S CONTINUED TO DROP TO 40%. PT REINTUBATED AND AMBU BAG USED TO VENTILATE. SAT'S CONTINUED TO DROP. ENDOTRACHEOTUBE PLACEMENT CONFIRMED. AMBU BAG CHANGED OUT AND PT'S SAT'S IMMEDIATELY CLIMBED TO 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMS/CARDYNE VENTISURE BTM DISTRIBUTER - TRI-ANIM HEALTH SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization