BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYJ

    MDR report key: 3062928 · Received April 12, 2013

    Report

    Report Number
    3004822415-2013-00003
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K830498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2013, IN (B)(6), AND INVOLVED A SUBJECT COMPANION 41 (SN (B)(4)) STATIONARY LIQUID OXYGEN UNIT AND A SUBJECT COMPANION 500 (SN (B)(4)) PORTABLE LIQUID OXYGEN UNIT. THE ALLEGED INCIDENT WAS REPORTED BY (B)(6) DISTRIBUTOR. THE ALLEGED INCIDENT DESCRIPTION IS THE FOLLOWING: THE PT SUFFERED BURNS ON HIS FACE FROM THE CANNULA (NOT A LIQUID OXYGEN BURN). (B)(6) DISTRIBUTOR DOES NOT HAVE ANY INFORMATION ON HOW EXACTLY IT HAPPENED. POLICE DISCOVERED POSSIBLE IMPROPER HANDLING OF AN ASTHMA-SPRAY NEAR A BURNING CANDLE MIGHT HAVE CAUSED THE INCIDENT, BUT IT COULD HAVE BEEN PT SMOKING. IT WAS NOTED THAT OTHER PEOPLE HAVE WITNESSED THE PT SMOKING WHILE USING THE EQUIPMENT. (B)(6)DISTRIBUTOR CONFIRMED THE PT TRAINING HAS BEEN INITIALLY CARRIED OUT. THE PT HAD BEEN WARNED IN THE PAST NOT TO SMOKE WHILST USING THE EQUIPMENT. ALL UNITS HAVE THE NEEDED WARNING LABELS; INCLUDING "NO SMOKING." (B)(6) DISTRIBUTOR STATES THAT THE INCIDENT WAS CAUSED BY PT'S MISUSE, NO FAULT OF THE SUBJECT COMPANION 41 OR THE SUBJECT COMPANION 500. REFERENCE REPORT# 3004822415-2013-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159124 BYJ UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC. C41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other