BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 30

    MDR report key: 7987758 · Received October 19, 2018

    Report

    Report Number
    3004972304-2018-00047
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    August 24, 2018
    Report Date
    February 22, 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

    UNIT IS GETTING RETURNED FOR EVALUATION BY MANUFACTURER. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ONE HOME-PATIENT HAD FILLED HIS HELIOS AND AFTER THAT THE QVD-VALVE ON THE VALVE DID NOT CLOSE. THE VESSEL EMPTIED ITSELF AT THE CUSTOMERS HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823419 LIBERATOR 30 UNIT, LIQUID-OXYGEN, STATIONARY BYJ CAIRE INC. 13258799

    Patients

    Seq Age Sex Outcome Treatment
    1