BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 8967077 · Received September 5, 2019

    Report

    Report Number
    3004972304-2019-00047
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    January 22, 2020
    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

    UNIT WAS RETURNED FOR AN EVALUATION. THE UNIT IN QUESTION IS WITHIN ALL MANUFACTURERS' SPECIFICATIONS EXCEPT FOR THE PRV WHICH SHOULD BE REPLACED AS PART OF MANUFACTURERS RECOMMENDED MAINTENANCE, THE ALLEGED INCIDENT REPORTED COULD NOT BE DUPLICATED AS THERE WAS NO LEAKING OR VENTING FROM THE QDV'S.

    Description of Event or Problem · 0

    PATIENT FILLED THE TWO VESSELS WITHIN 12 HRS TIME INTERVAL. DRIED THE QDV VALVE AN INVOLUNTARY DEPLETION OCCURRED. THERE WAS NO INJURY TO THE END USER.

    Additional Manufacturer Narrative · 1

    THE UNIT IS BEING RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STARTED WITH LOX ON (B)(6) 2019. HAS 2 PIECES. 30 LITER VESSELS AND 2X2 PARALLELLY CONNECTED STROLLER WITH A FLOW OF 10.0 LPM. THE PATIENT'S HUSBAND FILLS AT LEAST TWO STROLLERS PER DAY BUT THAT DAY SINCE THEY WOULD BE GONE FOR LONGER TIME SO, NEEDED ALL FOUR STROLLERS. THE FIRST TWO STROLLERS WERE FILLED WITHOUT PROBLEMS. HE WAITED FOR TWO HOURS, DRIED AND FILLED IN THE OTHER TWO. WHEN THE FILLING OF ONE OF THE LAST STROLLERS WAS COMPLETED AND IT WAS TO BE REMOVED FROM THE VESSEL, IT WAS FROZEN. JUST AT THAT TIME AN INVOLUNTARY DEPLETION OF THE VESSEL OCCURRED. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759403 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13256988

    Patients

    Seq Age Sex Outcome Treatment
    1