BEUDAMED
    FDA Adverse Event Death Summary report: N

    UKNOWN

    MDR report key: 21406031 · Received February 18, 2025

    Report

    Report Number
    3014810929-2025-00004
    Event Type
    Death
    Date Received
    February 18, 2025
    Date of Event
    January 4, 2025
    Report Date
    February 17, 2025
    Product Code
    CAT
    PMA / PMN Number
    K090007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT CAUSED BY USER SMOKING. NO EVIDENCE CANNULA MADE BY JUMAO. CANNULA WAS CONNECTED TO TRUAIR-5 OXYGEN CONCENTRATOR (MADE BY JUMAO) MODEL # 1-02C5L (GENERATOR, OXYGEN, PORTABLE, PROCODE: CAW) WITH SERIAL # (B)(6). THE OXYGEN CONCENTRATOR AT ISSUE FALLS WITHIN A RANGE OF SERIALS NUMBERS SUBJECT TO RECALL. RECALL NUMBER: Z-0795-2025. RECALL INITIATION DATE: 12/09/2024.

    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. THERE IS NO DATA PROVIDED TO SUPPORT THAT THE DEVICE(S) IN QUESTION MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668766 UKNOWN CANNULA CAT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Death