BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAIRE, INC.

    MDR report key: 1162852 · Received September 15, 2008

    Report

    Report Number
    1162852
    Event Type
    Death
    Date Received
    September 15, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING HOME RESIDENT ON CONTINUOUS 2L OF OXYGEN VIA NASAL CANNULA. LICENSED NURSE CHECKED AND FILLED PORTABLE OXYGEN TANK AT 3:15 P.M. WITHOUT INCIDENT. SAME LICENSED NURSE ASSISTED RESIDENT TO DINING ROOM FOR DINNER MEAL AT 4:40 P.M. OXYGEN TANK AFFIXED TO RESIDENT'S WHEEL CHAIR IN UPRIGHT POSITION, AND APPEARED TO BE OPERATING NORMALLY AT THIS TIME. MINUTES LATER, CERTIFIED NURSING ASSISTANTS SUMMONED LICENSED NURSE TO RESIDENT'S DINING TABLE. LICENSED NURSE OBSERVED THAT OXYGEN TANK, TUBING, AND NASAL CANNULA APPEARED FROZEN; AND, RESIDENT'S NOSE APPEARED WHITE AND COLD. AFTER INITIAL FIRST AID, RESIDENT BEGAN TO BLEED FROM NOSE AND BEGAN TO COUGH UP BLOOD. RESIDENT ADMITTED TO HOSPITAL IN 2008 AND DIED IN THE NEXT DAY. CAUSE OF DEATH PRESENTLY UNKNOWN TO USER FACILITY. (SEE SCANNED PAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE, INC. CAIRE STROLLER BYJ CAIRE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death CARDINAL HEALTH AIRLIFE ADULT CUSHION NASAL| CANNULA