BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON RCI

    MDR report key: 84553 · Received April 11, 1997

    Report

    Report Number
    84553
    Event Type
    Death
    Date Received
    April 11, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 11, 1997
    Manufacturer
    HUDSON RCI
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    74 YR OLD MALE FOUND CYANOTIC, UNRESPOSIVE WITH NO PULSE OR RESPIRATIONS. PT HAD OXYGEN REBREATHER MASK ON WITH NON-REBREATHER BAG NON-INFLATED. OXYGEN SET-UP HAD 3 WAY ADAPTOR AND WAS TURNED TO SETTING FOR ADMINISTRATION OF OXYGEN THROUGH A BUBBLER AND NASAL CANNULA. OXYGEN WAS COMING THROUGH NASAL CANNULA BUT NOT THROUGH THE NON-REBREATHER MASK. PNEUMONIA, CONGETIVE HEART FAILURE AND RENAL FAILURE. HAD HISTORY OF COPD, CANCER OF STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI ADULT NON-REBREATHER OXYGEN MASK BTM HUDSON RCI 81060-12893 4 29651
    2 PRECISION MEDICAL FLOW SELECTOR CAX PRECISION MED., INC. PM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death