BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAIRE COMPANION 41

    MDR report key: 1733893 · Received June 21, 2010

    Report

    Report Number
    3004822415-2010-00007
    Event Type
    Death
    Date Received
    June 21, 2010
    Date of Event
    April 20, 2008
    Report Date
    April 28, 2010
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K830498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAIRE WAS UNABLE TO OBTAIN THE UNIT FOR ANY INVESTIGATION, INSPECTION OR TESTING.

    Description of Event or Problem · 1

    ON (B) (6) 2010, CAIRE WAS INFORMED OF THE FOLLOWING INCIDENT; A PATIENT WAS ADMITTED FOR A TRACHEOSTOMY SURGERY TO CORRECT A SLEEP APNEA CONDITION. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS IN STABLE CONDITION WITH A 100% OXYGEN DEPENDENCY. A MEDICAL EQUIPMENT COMPANY PROVIDED THE PATIENT WITH OXYGEN SUPPLIED FROM A COMPANION 41 RESERVOIR. IT WAS REPORTED TO CAIRE, THAT ON (B) (6) 2008, THE PATIENT FAILED TO RECEIVE AN ADEQUATE OXYGEN SUPPLY, AND PERISHED FROM RESPIRATORY FAILURE ON (B) (6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE COMPANION 41 LIQUID OXYGEN, STATIONARY RESERVOIR BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death