BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE LIBERATOR 45

    MDR report key: 3415725 · Received October 11, 2013

    Report

    Report Number
    3004822415-2013-00014
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    December 30, 2012
    Report Date
    September 23, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT BASE LIQUID OXYGEN DEVICE, LIBERATOR 45 (SN (B)(4)), WAS RETURNED TO CAIRE FOR FURTHER INVESTIGATION AND TESTING. THE UNIT WAS NOT RECEIVED PACKAGED, HOWEVER IT WAS IN GOOD CONDITION. COMPONENTS ARE ALL PRESENT AND THERE IS NO DAMAGE TO COMPONENTS UNDER SHROUD. THERE WAS SLIGHT DAMAGE TO THE QDV NOTED, IT APPEARS THERE HAS BEEN A NUMBER OF IMPACTS AROUND THE VERY TOP OF THE EDGE OF THE QDV. LEAK TEST PASSED. THERE WAS NO VENTING OR LEAKING FROM THE QDV WHEN THE FUNCTION TEST WAS PERFORMED. THE INCIDENT REPORTER BY THE CUSTOMER COULD NOT BE REPLICATED. THERE WAS NO ISSUE WITH THE VESSEL WITNESSED TO ACCOUNT FOR THE VENTING OF THE VESSEL.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT VIA EMAIL BY (B)(6) ON (B)(6) 2013. "PT WAS FILLING THE A PORTABLE FROM THE UNIT. OXYGEN LEAKS SUDDENLY, 1-2 METERS IN HEIGHT AND BURNED A PART OF THE PT'S RIGHT HAND. PT WAS HOSPITALIZED AT 22.00 ON (B)(6) 2012 FOR 3RD DEGREE BURNS ON A PART OF HIS RIGHT HAND AND RELEASED AT 4.00 AM. A NURSE CHANGES THE DRESSING REGULARLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522321 CAIRE LIBERATOR 45 UNIT, LIQUID OXYGEN, BASE, RESERVOIR BYJ CAIRE, INC. 13262309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention