BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIR/OXYGEN MIXER

    MDR report key: 2442411 · Received February 3, 2012

    Report

    Report Number
    2020676-2012-00005
    Event Type
    Death
    Date Received
    February 3, 2012
    Date of Event
    October 27, 2011
    Report Date
    February 3, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE TESTING INDICATES THE DEVICE IS FUNCTIONING TO SPECIFICATIONS. TESTED THE DEVICE WITH CUSTOMER SUPPLIED HOSES. NO FAILURE OR PERFORMANCE ISSUES FOUND. THE FLOWMETER TAKES 3/4 OR A TURN TO A COMPLETELY SHUT OFF THE GAS SUPPLY. REJECTION TAG FOUND WITH DEVICE INDICATES CLINICIAN INADVERTENTLY TURNED OFF GAS SOURCE. CUSTOMER PROVIDED THE FOLLOWING INFORMATION: THE FLOW METER WAS TURNED OFF FOR MINUTES. PRIOR TO THE EVENT, A DECISION WAS MADE TO TAKE THE PATIENT OFF OF LIFE SUPPORT. UPON TAKING THE PATIENT OFF OF LIFE SUPPORT, PATIENT EXPIRED. THE EVENT WITH THE DEVICE WAS NOT THE CAUSE OF PATIENT TO TERMINATE.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER REPORTED KNOB ON THE FLOW METER WAS ACCIDENTALLY TURNED OFF, POSSIBLY BY SOMEONE WALKING BY AND BRUSHING AGAINST IT DURING CLINICAL USE DURING ECMO PROCEDURE. CUSTOMER REPORTED AN ANOXIC INJURY (NO FLOW OF OXYGEN TO THE BRAIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR/OXYGEN MIXER MIXER, BREATHING GASES, ANESTHESIA INHAL BZR SECHRIST INDUSTRIES, INC. 20099

    Patients

    Seq Age Sex Outcome Treatment
    1 Death