BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAIRE LIBERATOR 30

    MDR report key: 4005443 · Received July 22, 2014

    Report

    Report Number
    3004822415-2014-00010
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 18, 2014
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT BASE LIQUID OXYGEN UNIT, CAIRE LIBERATOR 30 (SN (B)(4)), WAS NOT RETURNED TO THE MFR FOR TESTING. HOWEVER, THE UNIT WAS RETURNED TO THE HOME HEALTH CARE FACILITY, WHERE IS WAS TESTED AND NO FAILURES WERE DETECTED WITH THE DEVICE. NORMAL MAINTENANCE WAS PERFORMED ON THE DEVICE AND THE QDV WAS EXCHANGED. THE UNIT WAS PLACED BACK INTO NORMAL ROTATION.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT VIA EMAIL ON (B)(6) 2014. THE ALLEGED INCIDENT WAS DESCRIBED TO THE COMPANY AS FOLLOWS: AFTER FILLING A PORTABLE UNIT, THE PT REMOVED THE PORTABLE AND THE QDV ON THE RESERVOIR WAS FROZEN OPEN. ALL THE CONTENTS OF THE RESERVOIR COMPLETELY EMPTIED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429257 CLAIRE LIBERATOR 30 UNIT, LIQUID OXYGEN, BASE, RESERVOIR BYJ CAIRE, INC. 20630525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other