BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE FNL H36T TF 10LPM

    MDR report key: 1990711 · Received February 8, 2011

    Report

    Report Number
    3004822415-2011-00001
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT UNIT IS IN-PROCESS OF BEING RETURNED TO CAIRE FOR FURTHER EVAL AND TESTING.

    Description of Event or Problem · 1

    THE ALLEGED EVENT HAPPENED ON (B)(6), 2011, AND WAS REPORTED TO THE DISTRIBUTOR IN (B)(4). THE ALLEGED INCIDENT INVOLVED A HELIOS 36, LIQUID OXYGEN RESERVOIR UNIT, AND IS DESCRIBED AS THE FOLLOWING: "THE VESSEL STARTED TO EMPTY AT A FAST RATE IN PT APARTMENT, VESSEL STARTED TO HISS AND OXYGEN WAS VAPORIZING RAPIDLY. ROOM FULL OF VAPOUR AND ICING ON THE FLOOR". IT WAS ALSO REPORTED THAT THE PT'S WIFE WAS FROSTBITTEN WHILE SHE TOUCHED THE VESSEL. CAIRE WAS NOTIFIED OF THIS EVENT ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE FNL H36T TF 10LPM LIQUID OXYGEN, STATIONARY RESERVOIR BYJ CAIRE, INC. B-700846-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other