BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERATOR

    MDR report key: 15262389 · Received August 19, 2022

    Report

    Report Number
    3004972304-2022-00028
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 7, 2022
    Report Date
    September 29, 2022
    Manufacturer
    CAIRE INC.
    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. CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THIS REPORT WAS ORIGINALLY SUBMITTED ON (B)(6) 2022, AND IS BEING RESUBMITTED ON (B)(6)2022 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH ON WEBTRADER DUE TO THE REPORT NUMBER.

    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 WAS RETURNED TO CAIRE FOR AN EVALUATION. THE UNIT HAD NO SIGNS OF DAMAGE ON THE UNIT OTHER THAN SCRATCHING ON THE SERIAL PLATE AND THE QDV. NO MAJOR DAMAGE. THE PROBLEM AS STATED IN THE EVENT WAS NOT REPLICATED. THE UNIT WAS IN WORKING CONDITION AND PASSED NORMAL FUNCTIONALITY.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED A NOTIFICATION OF THE BELOW INCIDENT FROM VITALAIRE AUSTRIA: ON (B)(6), THE SON OF A CUSTOMER INFORMED VITALAIRE THAT ON (B)(6), AT AROUND 3PM, THE DEVICE LIBERATOR LET OUT OXYGEN WITH NO CONTROL. THE SON COULD NOT SAY EXACTLY HOW IT HAPPENED. HIS MOTHER WAS BURNED ON HER FINGERS WHICH WERE ALSO SWOLLEN. SHE WENT TO TREATMENT AND EXAMINATIONS AT THE WELS STATE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942134 LIBERATOR UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 13261701

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization