BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 20906953 · Received December 11, 2024

    Report

    Report Number
    3004972304-2024-00016
    Event Type
    Death
    Date Received
    December 11, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 11, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK. THE DEVICE WAS INTENDED FOR EXPORT ONLY. CAIRE DETERMINED THAT THE EVENT MEETS REPORTING CRITERIA OUT OF AN ABUNDANCE OF CAUTION AND DUE TO THE DEATH OF THE PATIENT INVOLVED IN THIS INCIDENT. CAIRE CONCURS WITH THE INITIAL REPORTER (B)(4) THAT CAIRE'S EQUIPMENT DOES NOT APPEAR TO HAVE BEEN INVOLVED IN THE FIRE CAUSED BY PATIENT SMOKING, BUT CANNOT RULE OUT THE CONNECTION BASED ON AVAILABLE EVIDENCE. THE INFORMATION PROVIDED REPRESENTS THE BEST INFORMATION AVAILABLE TO CAIRE. THE AVAILABLE EVIDENCE SUPPORTS PATIENT SMOKING A CIGARETTE WHILE USING THE DEVICE. NO SMOKING WARNINGS ON THE EQUIPMENT AND IN THE IFU 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 UNIT IFU, WARNINGS STATE NOT TO ALLOW SMOKING OR OPEN FLAME NEAR 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. WARNINGS ALSO ADDRESS THE RISK OF OXYGEN SATURATION OF FABRICS WHEN REMOVING A CANNULA WHILE THE UNIT IS TURNED ON, LEADING TO INCREASED RISK OF FLASH FIRE. THIS CASE REPRESENTS PATIENT MISUSE OF THE DEVICE AND FAILURE TO HEED THE WARNINGS COMMUNICATED TO THE USER. LIBERATOR RISK ASSESSMENT SLOX-RA-001 REV T WAS REVIEWED AND DETERMINED TO BE ADEQUATE WITHOUT REVISION. THE USABILITY ASSESSMENT ADEQUATELY ADDRESSES USABILITY ERROR "PATIENT SMOKES OR USES AN OPEN FLAME NEAR THE DEVICE." MITIGATION INCLUDES VARIOUS WARNINGS ON THE EQUIPMENT AND IN THE INSTRUCTIONS FOR USE. "NO SMOKING" SYMBOLS ARE AFFIXED TO THE FACE OF THE UNITS. THROUGHOUT THE UNIT IFU, WARNINGS STATE NOT TO ALLOW SMOKING OR OPEN FLAME NEAR 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.

    Description of Event or Problem · 0

    AS REPORTED: "ON (B)(6) 2024, WE [(B)(4), DISTRIBUTOR] RECEIVED INFORMATION ABOUT THE DEATH OF A PATIENT WHO WAS BEING SUPPLIED WITH OXYGEN BY US [(B)(4), DISTRIBUTOR]. THE REASON FOR THE CAUSE OF DEATH: APARTMENT FIRE DUE TO SMOKING IN BED. OUR [(B)(4), DISTRIBUTOR] INITIAL INFORMATION (FORWARDED TO THE POLICE BY OUR SERVICE PARTNER) WAS THAT OXYGEN AND THUS THE LIBERATOR [BU, BASE UNIT] WERE SUPPOSEDLY NOT INVOLVED / OR WERE NOT IN USE. WE ALSO RECEIVED PHOTOS OF THE LIBERATOR. THE CONDITION OF THE BU IN THE PHOTOS SUGGESTS THAT THE BU WAS NOT DIRECTLY INVOLVED IN THE FIRE. 29TH OF NOVEMBER 2024: AFTER CONSULTING THE POLICE, WE RECEIVED FURTHER INFORMATION THAT THE USE OF OXYGEN CAN NEITHER BE CONFIRMED NOR RULED OUT. THIS MEANS THAT WE CANNOT RULE OUT A DIRECT CONNECTION BETWEEN OXYGEN THERAPY WITH THE LIBERATOR AND THE PATIENT'S DEATH. THE PATIENT ALSO HAD A STROLLER (3740545292C). ACCORDING TO INFORMATION FROM THE POLICE, IT WAS IN A ROOM THAT WAS FILLED WITH SMOKE, BUT NOT WHERE THE FIRE ACTUALLY BROKE OUT. WE THEREFORE ASSUME THAT THE STROLLER WAS NOT INVOLVED IN THE INCIDENT. WE WILL CONFISCATE BOTH DEVICES AND SEND THEM BACK TO OUR TECHNICAL CENTER. WE WILL ALSO REQUEST ACCESS TO THE FILE FROM THE POLICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745193 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death