BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR 30

    MDR report key: 10376802 · Received August 6, 2020

    Report

    Report Number
    3004972304-2020-00028
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    June 30, 2020
    Report Date
    September 8, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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." THE UNIT HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. THE DEVICE IN QUESTION NEEDS MAINTENANCE AND REPAIR. THE ALLEGED INCIDENT REPORTED COULD BE DUPLICATED DUE TO THE PRESCRIBED FLOW RATES NOT BEING SUPPLIED DUE TO LEAKS CAUSING LOW OPERATING PRESSURE.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY ADDITIONAL INFORMATION IS DISCOVERED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT CONCERNS A (B)(6) MALE PATIENT (WEIGHT AND HEIGHT UNKNOWN) WHO WAS TREATED WITH LIQUID OXYGEN (OXIGÉNIO MEDICINAL LINDE, BATCH NUMBER: 62031109019589 (1072304941)) AT UNKNOWN DOSAGE FOR UNKNOWN INDICATION SINCE UNKNOWN DATE. THE PATIENT'S MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2020, DURING THE NIGHT, THE PATIENT WOKE UP BREATHLESSNESS. HE MEASURED THE O2 SATURATION AND IT WAS AT 74%. HE CHANGED THE HOME LOX CONTAINER AND INCREASED THE FLOW TO 10L/MIN. THE SPO2 INCREASED TO 91%, SO THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836600 LIBERATOR 30 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13256929

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other