BEUDAMED
    FDA Adverse Event Death Summary report: N

    VAPOTHERM

    MDR report key: 639315 · Received September 8, 2005

    Report

    Report Number
    639315
    Event Type
    Death
    Date Received
    September 8, 2005
    Date of Event
    August 30, 2005
    Report Date
    September 8, 2005
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN END STAGE PULMONARY FIBROSIS AND REQUIRED THE VAPOTHERM AT 36 LITERS OF OXYGEN IN ORDER TO SUSTAIN O2 SATURATIONS OF 88%. VAPOTHERM MACHINE SUSEQUENTLY BEGAN TO ALARM "SYSTEM FAILURE". THE NURSE WAS UNABLE TO TROUBLESHOOT THE MACHINE. RESPIRATORY THERAPY WAS CALLED IMMEDIATELY AS PATIENT WAS RAPIDLY DESATURATING WITH JUST THE NON-REBREATHER MASK. STAFF BAGGED THE PATIENT AND THEN PLACED SEVERAL NASAL CANNULAS AT ONCE. A NEW VAPOTHERM WAS OBTAINED, AND AN ABG WAS DRAWN. AS SOON AS THE ABG WAS DRAWN, THE PATIENT BECAME UNRESPONSIVE AND A CODE WAS CALLED. ACLS PROTOCOL REQUIRED - THE PATIENT WAS INTUBATED AND TRANSFERRED TO ICU. PATIENT REMAINED ON VENTILATOR AND SEVERAL MEDS FOR BLOOD PRESSURE MAINTENANCE, COMPLETE RENAL SHUTDOWN BEGAN. PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM HIGH FLOW NASAL CANNULA BTT VAPOTHERM, INC. 2000I NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| R