BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 8771198 · Received July 9, 2019

    Report

    Report Number
    3004972304-2019-00038
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    May 22, 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 AN 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

    THE CUSTOMER GOT THEIR VESSELS EXCHANGED ON (B)(6) 2019. HE REPLENISHED HIS STROLLER. THE PATIENT IS USED TO WITH FILLING AND USING TIME, THE CONTENT METER ON THE STROLLER AND THE SOUND CHANGE AT THE ACTUAL FILLING TO INTERRUPT THE FILLING WHEN THE THERMOS IS FULL AND DO NOT RISK "OVERFILLING". HE DRIES THE LIBERATOR AND STROLLER'S QDV VALVE BEFORE FILLING. WHEN THE STROLLER WAS FULL, HE REMOVED THE THERMOS FROM THE LIBERATOR. IN THIS MODE, THE QDV VALVE DOES NOT CLOSE AND THE LIBERATOR EMPTIES. STROLLER AND LIBERATOR QDV VALVE WERE DRY AND ROOM TEMPERATURE WHEN FILLING BEGAN. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566711 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13258799

    Patients

    Seq Age Sex Outcome Treatment
    1