BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYJ

    MDR report key: 3020606 · Received March 21, 2013

    Report

    Report Number
    3004822415-2013-00002
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K993220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2013, AT 9:00 AM. THE ALLEGED INCIDENT INVOLVED A SUBJECT CAIRE HELIOS MARATHON H850 PORTABLE LIQUID OXYGEN DEVICE (SN (B)(4)). THE ALLEGED INCIDENT WAS REPORTED TO THE COMPANY ON (B)(6) 2013, BY THE HOME-CARETAKER. THE HOME-CARETAKER STATED THE ALLEGED INCIDENT OCCURRED IN THE PT'S HOME IN (B)(6). THE HOME-CARETAKER STATES SHE WAS VERY UNFAMILIAR WITH THE UNIT, AND HAD NEVER HANDLED LIQUID OXYGEN EQUIPMENT, NEVER BEEN TRAINED ON HOW TO USE LIQUID OXYGEN EQUIPMENT, AND HAD NEVER READ THE PT OPERATING OR USER MANUAL INSTRUCTIONS. THE HOME-CARETAKER DESCRIBES THE ALLEGED INCIDENT AS THE FOLLOWING: "AS SHE TRIED TO CHECK THE CONTENTS (LIQUID LEVEL) OF THE UNIT, SHE INADVERTENTLY PULLED THE VENT VALVE LEVER. SHE WAS HOLDING THE UNIT UP WHILE SHE INCORRECTLY PULLED THE VENT VALVE LEVER, AND LIQUID OXYGEN GAS AND/OR LIQUID WAS EXPELLED, CAUSING A SMALL BLISTER ON HER STOMACH." THE HOME-CARETAKER STATED NOT LIFE THREATENING AND THE BLISTER WAS HEALING WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118327 BYJ UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC. H850

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other