BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 8771194 · Received July 9, 2019

    Report

    Report Number
    3004972304-2019-00039
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    May 23, 2019
    Report Date
    September 13, 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

    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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, WHEN THE FATHER OF THE PATIENT FILLED OVER TO THE STROLLER, THE LIBERATOR'S QDV VALVE DID NOT SHUT DOWN BY ITSELF BUT IT LEAKS HEAVILY FROM IT WHEN THE STROLLER WAS REMOVED. THE LIBERATOR EMPTIED COMPLETELY. THEY HAD OPENED THE WINDOW AND CLOSED THE DOOR OF THE ROOM WHERE THE LIBERATOR WAS STANDING. THEY HAVE HAD LOX LIBERATOR FOR FOUR WEEKS BACK AND THE PARENTS HAD RECEIVED INSTRUCTIONS ON THE OPERATION ON TWO REPEATED OCCASIONS. THE FATHER SAID THAT THEY HAVE BEEN CAREFUL TO WIPE THE QDV VALVES ON BOTH THE LIBERATOR AND THE STROLLER BEFORE FILLING. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566710 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13256988

    Patients

    Seq Age Sex Outcome Treatment
    1