BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-36 RESERVOIR, JAPAN

    MDR report key: 1592411 · Received January 27, 2010

    Report

    Report Number
    1825511-2010-00001
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 18, 2009
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT MANUAL 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 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: THE DEVICE STOPPED DELIVERING OXYGEN DURING USE AT THE PATIENT'S HOME. THE PATIENT'S CONDITION DETERIORATED, AND THEY WERE TRANSPORTED TO THE HOSPITAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-36 RESERVOIR, JAPAN LIQUID OXYGEN RESERVOIR BYJ PLAINFIELD-LOX-RX H36

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention