BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERATOR

    MDR report key: 20130506 · Received September 3, 2024

    Report

    Report Number
    3004972304-2024-00010
    Event Type
    Death
    Date Received
    September 3, 2024
    Date of Event
    August 10, 2024
    Report Date
    September 3, 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. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO (B)(6) FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2012.

    Description of Event or Problem · 0

    AS REPORTED: THE LEVEL INDICATOR SHOWED THAT THE DEVICE WAS STILL HALF FULL. THE DEVICE WAS DISCOVERED AROUND 11:00 P.M PUT INTO OPERATION (12 L/MIN). DURING AN INSPECTION (AROUND 1:30 P.M.) THE DEVICE STILL HAS OXYGEN DELIVERED AND THE RESIDENT LIVED. WHEN THE RELATIVES ENTERED THE ROOM ABOUT AN HOUR LATER, THERE WAS NO OXYGEN DELIVERY AND THE FILL LEVEL INDICATOR WAS RED. AT THIS POINT THE RESIDENT HAD ALREADY DIED. NOTE: CAIRE LIBERATOR LIQUID OXYGEN SYSTEMS PROVIDE SUPPLEMENTAL OXYGEN AND ARE NOT INTENDED OR MARKETED FOR LIFE SUPPORT FUNCTIONS PER THE DEVICE'S TECHNICAL DOCUMENTATION. A SECONDARY SOURCE OF SUPPLEMENTAL OXYGEN MUST BE ON HAND PER THE DEVICE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899941 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 14807323

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death