BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 60

    MDR report key: 16478823 · Received March 3, 2023

    Report

    Report Number
    3004972304-2023-00003
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    July 6, 2020
    Report Date
    March 3, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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. UNIT IS QUARANTINED AT CAIRE'S DISTRIBUTOR AND IS NOT AVAILBLE FOR INVESTIGATION AT CAIRE.

    Description of Event or Problem · 0

    PATIENT HAD A CAREGIVER PRESENT. THE PATIENT'S HUSBAND WAS FILLING A PORTABLE LOX UNIT AT A LOX TANK. SOMETHING OCCURRED WITH THE TANK AND/OR THE PORTABLE AND LOX MATTER SPRAYED OUT, CAUSING A CRYO BURN ON THE CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859084 LIBERATOR 60 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 11069020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other