BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 1893224 · Received November 1, 2010

    Report

    Report Number
    3004822415-2010-00015
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAIRE IS IN-PROCESS OF HAVING THE SUBJECT UNIT RETURNED FOR TESTING AND EVALUATION.

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT HAPPENED ON (B)(6) 2010, AT (B)(6) HOSPITAL, IN (B)(6). THE INCIDENT REPORT FORM PROVIDED FROM THE HOSPITAL REPORTS THE ALLEGED INCIDENT AS FOLLOWS: "PATIENT FAMILY WHEELED PATIENT TO THE HALLWAY. HIGH FLOW 02 TUBING FILLED WITH FROZEN FLUID. NASAL CANNULA BROKE OFF CRACKED FLOW CONTROL VALVE, SITTING ON PATIENT'S LAP. PORTABLE TANK HANGING FROM WHEELCHAIR HANDLES. ALL TUBING AND TANK REMOVED FROM PATIENT BY NURSE." THE UNKNOWN PATIENT'S NOSE WAS ALLEGEDLY BURNED. THE HOSPITAL NOTES THAT LIDOCAINE AND SILVADENE WAS USED/ APPLIED.

    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