BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIRE LIBERATOR 30

    MDR report key: 3810678 · Received March 24, 2014

    Report

    Report Number
    3004822415-2014-00004
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 18, 2013
    Report Date
    March 20, 2014
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT VIA EMAIL ON (B)(6) 2014. THE ALLEGED INCIDENT WAS DESCRIBED TO THE COMPANY AS FOLLOWED. WHILE FILLING THE UNIT THE QDV FROZE OPEN AND GASEOUS OXYGEN LEAKED THROUGH THE VALVE. THE PATIENT CARRIED THE UNIT OUTSIDE AND LET IT EMPTY. THE TRANSPORTATION COMPANY REPLACED THE UNIT WITH A NEW ONE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172788 CAIRE LIBERATOR 30 BYJ CAIRE, INC. 20630525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other