BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 11100581 · Received December 31, 2020

    Report

    Report Number
    3004972304-2020-00037
    Event Type
    Death
    Date Received
    December 31, 2020
    Date of Event
    December 1, 2020
    Report Date
    May 12, 2021
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE UNIT HAS BEEN RETURNED FROM POLICY CUSTODY TO THE CUSTOMER. CAIRE IS ATTEMPTING TO COORDINATE THE RETURN OF THE UNIT FOR AN EVALUATION AND GATHER ADDITIONAL INFORMATION ABOUT THE INCIDENT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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. RIMKUS CONSULTING, A THIRD-PARTY CONSULTING COMPANY, COMPLETED AN INVESTIGATION OF THE UNIT. BELOW IS A SUMMARY OF THE CONCLUSIONS IN THE TEST REPORT: 1. THE FIRST ITEM IGNITED, IGNITION SOURCE, AND CAUSE OF THE FIRE CANNOT BE ESTABLISHED BASED ON CRITERIA AND GUIDELINES OF NFPA 921 - GUIDE FOR FIRE AND EXPLOSION INVESTIGATIONS. 2. SIGNIFICANT INFORMATION AND DETAILS REGARDING THE SCENE ARE UNAVAILABLE TO INTERPRET AND CONFIRM THE ORIGIN OF THE FIRE WITH RESPECT TO THE APPLIANCE, ELIMINATE OTHER POSSIBLE SOURCES OF COMPETENT IGNITION, OR CONCLUSIVELY IDENTIFY THE CAUSE OF THE FIRE. 3. WHILE THE EVIDENCE IS INSUFFICIENT TO IDENTIFY THE ORIGIN OR CAUSE OF THE FIRE, THE LIBERATOR 45 THAT WAS EXAMINED REVEALED NO EVIDENCE OF INTERNAL FAILURE RELATED TO THE FIRE'S CAUSE. SIGNIFICANT INFORMATION AND DETAILS REGARDING THE SCENE ITSELF WERE UNAVAILABLE FROM THE FIRE SERVICE OR THE POLICE TO INTERPRET AND CONFIRM THE CAUSE AND THE ORIGIN OF THE FIRE. WHILE THE AVAILABLE EVIDENCE IS INSUFFICIENT TO CONCLUSIVELY IDENTIFY THE ORIGIN OR CAUSE OF THE FIRE, THE UNIT EXAMINED DID NOT INDICATE EVIDENCE OF CATASTROPHIC FAILURE, NOR EXHIBIT EVIDENCE OF BEING THE SOURCE OF THE FIRE OR EXPLOSION.

    Additional Manufacturer Narrative · 1

    THE UNIT IS IN POLICE CUSTODY. CAIRE IS ATTEMPTING TO COORDINATE THE RETURN OF THE UNIT FOR AN EVALUATION AND GATHER ADDITIONAL INFORMATION ABOUT THE INCIDENT. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON TUESDAY, (B)(6), AN ACCIDENT INVOLVING A FIRE AND EXPLOSION HAPPENED AT THE HOME OF A PATIENT USING HOME LOX SINCE (B)(6) 2019. ONE OF FIVE RESERVOIRS PRESENT, A LIBERATOR 45, WAS BURNED AND TAKEN BY THE POLICE FOR FURTHER INVESTIGATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE ABOUT THE CAUSE OF THE ACCIDENT. THE PATIENT PASSED AWAY FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565273 LIBERATOR STATIONARY, LIQUID OXYGEN BYJ 13262253

    Patients

    Seq Age Sex Outcome Treatment
    1 Death