BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 18016724 · Received October 26, 2023

    Report

    Report Number
    3004972304-2023-00016
    Event Type
    Death
    Date Received
    October 26, 2023
    Date of Event
    October 10, 2023
    Report Date
    July 23, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. UDI RELATED DATA QUALITY UPDATES ONLY. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER THE FOLLOWING: RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2012. RULE 21 CFR 801.30(8). THE DEVICE WAS INTENDED FOR EXPORT ONLY.

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE INFORMATION PROVIDED REPRESENTS THE BEST INFORMATION AVAILABLE TO CAIRE. THE DEVICE(S) WILL NOT BE AVAILABLE FOR ENGINEERING EVALUATION. THE END USER REPORTED SMOKING A CIGARETTE AT THE TIME OF REFILLING A PORTABLE LIQUID OXYGEN UNIT FROM A STATIONARY UNIT. NO SMOKING WARNINGS WERE REVIEWED AND DEEMED ADEQUATE IN THE COURSE OF THE INVESTIGATION. "NO SMOKING" SYMBOLS (REG#: P002) ARE AFFIXED TO THE FACE OF THE UNITS. THROUGHOUT THE PORTABLE AND STATIONARY UNIT IFUS, WARNINGS STATE NOT TO ALLOW SMOKING OR OPEN FLAME WITHIN 10 FEET OF THE DEVICE AND TO KEEP ALL FLAMMABLE MATERIALS AWAY FROM THE EQUIPMENT. ADDITIONAL WARNINGS STATE THAT SMOKING WHILE WEARING AN OXYGEN CANNULA CAN CAUSE FACIAL BURNS AND POSSIBLY RESULT IN DEATH, AND THAT LIQUID OXYGEN SPILLS CAN INCREASE THE FLAMMABILITY OF SURROUNDING MATERIALS IF AN IGNITION SOURCE IS PRESENT. NO FURTHER INVESTIGATION IS FORTHCOMING. THIS ISSUE WILL BE MONITORED FOR TRENDING AND INCLUDED IN POST MARKET SURVEILLANCE REVIEW AND PERIODIC SAFETY UPDATE REPORTS.

    Description of Event or Problem · 0

    AS REPORTED: END USER WAS SMOKING WHILE FILLING A PORTABLE LIQUID OXYGEN UNIT FROM A STATIONARY UNIT. THIS INCIDENT APPARENTLY RESULTED IN A HOUSE FIRE AND THE PATIENT DIED IN THE HOSPITAL. THE ESSEN CRIMINAL POLICE GOT INVOLVED AND CONFISCATED THE AFFECTED DEVICES. AFTER SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT, NO ADDITIONAL INFORMATION WAS AVAILABLE. A POLICE REPORT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432432 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 14807323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death