BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME LIQUID OXYGEN DEVICE

    MDR report key: 28381 · Received November 9, 1995

    Report

    Report Number
    39778-1995-09003
    Event Type
    Malfunction
    Date Received
    November 9, 1995
    Date of Event
    October 26, 1995
    Report Date
    November 3, 1995
    Manufacturer
    CAIRE, INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN DISCONNECTING PORTABLE UNIT FROM RESERVOIR UNIT, QDV ON BASE CAME LOOSE AND SPILLED LIQUID OXYGEN ON PT'S HAND AND FOREARM. ONE BLISTER OCCURRED, NO OTHER INJURIES. QDV NUT HAD LOOSENED CAUSING LIQUID OXYGEN TO COME OUT QDV SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME LIQUID OXYGEN DEVICE HOME LIQUID OXYGEN DEVICE CAW CAIRE, INC. 10665049

    Patients

    Seq Age Sex Outcome Treatment
    1 *