BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 8348619 · Received February 18, 2019

    Report

    Report Number
    3004972304-2019-00009
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    September 17, 2018
    Report Date
    July 24, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION. THE UNIT IN QUESTION IS WITHIN ALL MANUFACTURERS' SPECIFICATIONS, EXCEPT FOR A SMALL VAPOR LEAK WHICH ON THE VESSELS INTERNAL PLUMBING WHICH WOULD HAVE NO BEARING TO THE ALLEGED INCIDENT REPORTED. THE ALLEGED INCIDENT REPORTED COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COMPLAINT ABOUT EMPTYING HOME LOX VESSEL. INCIDENT OCCURRED (B)(6) 2018. FILLING FROM HOME LOX VESSEL TO STROLLER HAS BEEN DONE AS USUAL. NO PROBLEM TO LOOSEN THE STROLLER FROM THE VESSEL. NO "OVERFILLING" HAS OCCURRED. DIRECTLY AFTER FILLING, THE VESSEL BEGINS TO SPRAY THICK SMOKE AND LEAK BLUE LIQUID FROM QDV-VALVE. THE VESSEL WAS MOVED AND PLACED CLOSED TO THE PATIO DOOR. AFTER APPROX. 10 MINUTES THE VESSEL WAS EMPTY. THE PATIENT HAS USED THE PRODUCT LONGER THAN ONE WEEK AND TWO TIMES PER DAY, HAS USED SEVERAL VESSEL DURING THIS TIME. THE CUSTOMER HAS BEEN INFORMED THAT IT'S VERY IMPORTANT THAT THE ODV-VALVE IS DRY WHEN FILLING TO THE STROLLER. NO SUSPICION OF ANY USER-ERROR. NO HARM ON THE PATIENT OR OTHER PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141214 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13256988

    Patients

    Seq Age Sex Outcome Treatment
    1