BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPANION 41

    MDR report key: 820822 · Received February 17, 2007

    Report

    Report Number
    1825511-2007-00002
    Event Type
    Other
    Date Received
    February 17, 2007
    Date of Event
    December 30, 2006
    Report Date
    January 18, 2007
    Manufacturer
    PURITAN BENNETT (LOX)
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT ONE OF THE C41 UNITS WAS NOT DELIVERING FLOW AS INTENDED. THE DEVICES INVOLVED WERE EVALUATED BY TYCO. THE EVALUATION CONCLUDED THAT BOTH OF THE C41 STATIONARY UNITS OPERATED WITHIN SPECIFICATION. DURING THE EVALUATION IT WAS DISCOVERED THAT ONE OF THE EXTERNAL HUMIDIFIERS (NOT MANUFACTURED BY PURITAN-BENNETT) WAS LEAKING, ALLOWING THE GASEOUS OXYGEN TO ESCAPE BEFORE REACHING THE PATIENT. OPERATING INSTRUCTIONS WARN: "OXYGEN SUPPLIED FROM THIS EQUIPMENT IS FOR SUPPLEMENTAL USE AND IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THIS EQUIPMENT IS NOT INTENDED FOR USE BY PATIENTS WHO WOULD SUFFER IMMEDIATE, PERMANENT, OR SERIOUS HEALTH CONSEQUENCES AS A RESULT OF AN INTERRUPTION IN THEIR OXYGEN SUPPLY."

    Description of Event or Problem · 1

    IT WAS REPORTED: 1) A PATIENT WAS USING TWO C41 STATIONARY UNITS WITH EXTERNAL HUMIDIFIERS ATTACHED FOR THEIR OXYGEN SUPPLY. 2) THE PATIENT'S OXYGEN SATURATION WAS FOUND TO BE LOW. 3) THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR EVALUATION AND WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 41 STATIONARY LIQUID OXYGEN SYSTEM BYJ PURITAN BENNETT (LOX) C41 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention