BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 2263038 · Received September 20, 2011

    Report

    Report Number
    3004822415-2011-00010
    Event Type
    Injury
    Date Received
    September 20, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, CAIRE INC. WAS NOTIFIED BY A HEALTHCARE FACILITY OF AN ALLEGED INCIDENT INVOLVING A COMPANION 1000 PORTABLE LIQUID OXYGEN UNIT. THE ALLEGED INCIDENT OCCURRED ON (B)(6), 2011, IN (B)(6). IT WAS REPORTED TO CAIRE INC. THAT THE UNKNOWN PATIENT WAS AT DIALYSIS IN THE DOCTOR'S OFFICE WHEN THE PATIENT HEARD A LOUD POP AND SAW LIQUID COMING UP THE TUBING TOT HE PATIENT'S TRACHE. THE PATIENT REACHED TO REMOVE THE TUBING FROM THE TRACHE AND BURNT BOTH THUMBS. THE TUBING WAS REMOVED AND THERE WAS NO FURTHER DAMAGE/INJURY REPORTED. THE UNIT WAS REMOVED FROM SERVICE AND RETURNED TO THE HEALTHCARE FACILITY, WHERE IT WAS FILLED AND TESTED. THE HEALTHCARE FACILITY REPORTED THAT THE UNIT FUNCTIONED PROPERLY AND EMPTIED NORMALLY. THE UNIT IS IN-PROCESS OF BEING RETURNED TO CAIRE INC. FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 1000 UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other