BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 12076134 · Received June 28, 2021

    Report

    Report Number
    3004972304-2021-00013
    Event Type
    Death
    Date Received
    June 28, 2021
    Date of Event
    June 3, 2021
    Report Date
    September 7, 2021
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    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. TWO OF THE THREE DEVICES PRESENT AT THE SCENE OF THE INCIDENT WERE RETURNED TO CAIRE FOR AN EVALUATION. THE LIBERATOR (S/N (B)(6)) IS IN POLICE CUSTODY AND WAS NOT RETURNED TO CAIRE. THE EVALUATION, CONDUCTED BY CAIRE PERSONNEL, OF THE RETURNED LIBERATOR 45 STATIONARY LIQUID OXYGEN RESERVOIR (S/N (B)(6)) AND STROLLER LIQUID OXYGEN PORTABLE UNIT (S/N (B)(6)) COULD NOT FIND THE ROOT CAUSE OF THE ADVERSE EVENT. BOTH THE RESERVOIR AND THE PORTABLE UNIT SUSTAINED SUBSTANTIAL FIRE DAMAGE AND WERE DEEMED NON-FUNCTIONAL AND NOT SUITABLE FOR ANY FUNCTIONAL TESTING. ONLY A VISUAL INSPECTION OF THE TEST UNITS COULD BE CONDUCTED. A SEPARATE INVESTIGATION CONDUCTED BY AUSTRIAN AUTHORITIES STATED THAT THE FIRE WAS DUE USER NEGLIGENCE. THEY SPECIFIED THAT THE FIRE WAS VERY LIKELY THE RESULT OF SMOKING IN CONJUNCTION WITH THE USE OF MEDICATED OXYGEN.

    Additional Manufacturer Narrative · 1

    CAIRE IS CONTACTING THE INITIAL REPORTER OF THE INCIDENT ((B)(4)) TO GATHER MORE INFORMATION ABOUT THE INCIDENT, AND WELL AS TO COORDINATE THE RETURN OF THE UNITS FOR AN EVALUATION, IF POSSIBLE. THE THREE DEVICES (2 LIBERATORS, 1 STROLLER) PRESENT AT THE SCENE OF THE INCIDENT ARE CURRENTLY IN POLICE CUSTODY. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FIRE OCCURRED IN THE APARTMENT OF A MEDICAL LOX PATIENT. THE FIRE BRIGADE ENTERED THE APARTMENT WITH RESPIRATORY EQUIPMENT AND BROUGHT THE PATIENT OUT OF THE APARTMENT. THE EMERGENCY RESCUE SERVICE GAVE FIRST AID AND THE PATIENT WAS BROUGHT TO THE HOSPITAL, WHERE HE PASSED AWAY. THERE WAS A CALL TO THE (B)(4) EMERGENCY NUMBER BEFORE THE ACCIDENT. A PERSON REPORTED THAT THE PORTABLE (SIDE FILL) IS FROZEN ON THE FILLING CONNECTOR OF THE LIBERATOR. THE PERSON WAS INSTRUCTED ACCORDING TO THE USER MANUAL AND WITH SAFETY ADVICE. THE PATIENT WAS DELIVERED WITH LOX SINCE 2012. TWO LIBERATOR DEVICES AND A STROLLER WERE PRESENT AT THE SCENE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972568 LIBERATOR STATIONARY, LIQUID OXYGEN BYJ 13261699

    Patients

    Seq Age Sex Outcome Treatment
    1 Death