BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAIRE LIBERATOR 45

    MDR report key: 3530605 · Received November 12, 2013

    Report

    Report Number
    3004822415-2013-00018
    Event Type
    Other
    Date Received
    November 12, 2013
    Date of Event
    July 6, 2013
    Report Date
    November 11, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT THAT OCCURRED AT (B)(6). THE ALLEGED INCIDENT WAS DESCRIBED TO THE COMPANY AS FOLLOWED. ON (B)(6) 2013 STAFF WAS ALERTED TO AN EMERGENCY IN A PATIENT LIVING IN THE RETIREMENT HOME. THE REASON WAS ESCAPE OF OXYGEN FROM THE BASE TANK DURING THE FILLING PROCESS AND THE PORTABLE DEVICE CANNOT BE DECOUPLED FROM THE BASE TANK. ONCE STAFF ARRIVED ON SCENE, IT WAS NOTED THAT THE PORTABLE DEVICE EASILY DETACHED FROM THE BASE UNIT. PROPER FILLING PROCEDURES WERE EMPHASIZED. THUS, WE ASSUME THAT THE CAUSE IS NOT THE ESCAPE OF OXYGEN FROM THE BASE TANK OR A DEFECT IN THE LIQUID OXYGEN SYSTEM, BUT APPARENTLY WERE DUE TO A FAULTY CHARGING OF THE PORTABLE DEVICE BY THE NURSE ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585093 CAIRE LIBERATOR 45 UNIT, LIQUID OXYGEN, BASE, RESERVOIR BYJ CAIRE, INC. 13261701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other