BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR

    MDR report key: 7996777 · Received October 23, 2018

    Report

    Report Number
    3004972304-2018-00048
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    September 14, 2018
    Report Date
    February 22, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT WAS RETURNED FOR EVALUATION. THE UNIT IN QUESTION IS WITHIN ALL MANUFACTURERS' SPECIFICATIONS. THE ALLEGED INCIDENT REPORTED COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    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 APPR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836936 LIBERATOR UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13256988

    Patients

    Seq Age Sex Outcome Treatment
    1