BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPASS TRUAIRE

    MDR report key: 21179104 · Received January 17, 2025

    Report

    Report Number
    21179104
    Event Type
    Death
    Date Received
    January 17, 2025
    Date of Event
    January 4, 2025
    Report Date
    January 8, 2025
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT SUFFERED FLASH BURN TO FACE WHILE SMOKING AND USING OXYGEN CONCENTRATOR. PATIENT SUSTAINED 2ND DEGREE BURNS TO FACE. PATIENT WAS TRANSFERRED TO TRAUMA CENTER AND WAS PLACED ON A VENTILATOR. PATIENT WAS EXTUBATED SAME DAY AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006575 COMPASS TRUAIRE OXYGEN CONCENTRATOR CAW COMPASS HEALTH BRANDS O2C5L

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| D| L LIFT CHAIR| O2 BACKUP E CART| O2 USP - BACKUP E CYLINDER| O2 USP - E CYLINDER | OXYGEN REGULATOR - HIGH FLOW| SVN - SMALL VOLUME NEBULIZER