BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIOS U36

    MDR report key: 2359610 · Received October 6, 2011

    Report

    Report Number
    3004822415-2010-00017
    Event Type
    Other
    Date Received
    October 6, 2011
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT UNIT, HELIOS U36 STATIONARY LIQUID OXYGEN RESERVOIR WAS RETURNED ON AUGUST 19, 2010, FOR INSPECTION AND EVALUATION. THE SUBJECT UNIT FAILED A PRESSURE HOLD TEST, WHICH WOULD HAVE CAUSED A PORTABLE UNIT TO FILL VERY SLOWLY. THE SUBJECT UNIT WAS NOT ABLE TO REPRODUCE THE ALLEGED INCIDENT OF "BURSTING" OXYGEN.

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT TOOK PLACE IN (B)(6), ON (B)(6) 2010. THE ALLEGED INCIDENT INVOLVED A HELIOS 036L, STATIONARY LIQUID OXYGEN RESERVOIR AND A MARATHON, PORTABLE LIQUID OXYGEN DEVICE. AFTER BEGINNING THE FILL PROCESS, IT WAS NOTED THAT THE FILLING PROCESS WAS SLOWER THAN NORMAL. WHEN THE CUSTOMER REMOVED THE PORTABLE DEVICE AFTER IT WAS FULL, THE STATIONARY VESSEL STARTED TO BURST OXYGEN OUT. THE CUSTOMER WAS ABLE TO MOVE THE DEVICE OUT OF THE BUILDING AND AFTER A WHILE THE LEAKAGE STOPPED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS U36 LIQUID OXYGEN, STATIONARY RESERVOIR BYJ CAIRE, INC. U36EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other