BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPANION 31

    MDR report key: 842460 · Received April 25, 2007

    Report

    Report Number
    1825511-2007-00007
    Event Type
    Death
    Date Received
    April 25, 2007
    Date of Event
    July 27, 2005
    Report Date
    March 27, 2007
    Manufacturer
    PURITAN BENNETT (LOX), CRYOGENIC DIVISION
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MOTHER REPORTS THAT THE FDA HAS INVESTIGATED THIS MATTER. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. USER GUIDE WARNS: "OXYGEN SUPPLIED FROM THIS EQUIPMENT IS FOR SUPPLEMENTAL USE AND IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THIS EQUIPMENT IS NOT FOR USE BY PTS 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: A PATIENT WAS DELIVERED A C31 LIQUID OXYGEN STATIONARY UNIT TO HIS HOME. THE PT HAD REPORTED TO THE HOMECARE PROVIDER THAT THE UNIT APPEARED DEFECTIVE. THE PATIENT UTILIZED AN ALTERNATE LIQUID OXYGEN UNIT FOR HIS THERAPY AND AVOIDED USING THE C31. A REPRESENTATIVE FOR THE HOMECARE PROVIDER WENT TO THE HOME TO SERVICE THE LIQUID OXYGEN EQUIPMENT. THE HOMECARE REPRESENTATIVE PLACED THE PT ON THE C31 UNIT THAT WAS ALLEGED TO BE DEFECTIVE AND LEFT THE HOME. THE PATIENT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 31 STATIONARY LIQUID OXYGEN SYSTEM BYJ PURITAN BENNETT (LOX), CRYOGENIC DIVISION C31 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death