BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUAIRE-5 OXYGEN CONCENTRATOR

    MDR report key: 23578734 · Received November 18, 2025

    Report

    Report Number
    3014810929-2025-00021
    Event Type
    Death
    Date Received
    November 18, 2025
    Date of Event
    January 24, 2025
    Report Date
    November 17, 2025
    Manufacturer
    JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
    Product Code
    CAW
    PMA / PMN Number
    K090007
    Removal / Correction Number
    Z-0795-2025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO INCIDENT CONTINUES. MANUFACTURER AND DISTRIBUTOR ARE WORKING DILIGENTLY TO DETERMINE IF AND WHOSE DEVICE WAS PRESENT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO INCIDENT CONTINUES. MANUFACTURER AND DISTRIBUTOR ARE WORKING DILIGENTLY TO DETERMINE IF AND WHOSE DEVICE WAS PRESENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, OUR CLIENT PASSED AWAY WHILE USING AN OXYGEN TANK THAT WAS MANUFACTURED AND/OR DISTRIBUTED BY YOU, WHEN THE TANK MALFUNCTIONED. THE OXYGEN TANK WAS SUPPLIED BY (B)(6) AND WAS MANUFACTURED BY COMPASS HEALTH BRANDS. AS A RESULT OF THIS DEFECT AND MALFUNCTION, OUR CLIENT PASSED AWAY FROM A RESIDENTIAL FIRE DUE TO THE RECALL OF THE OXYGEN MACHINE PROVIDED WHICH RESULTED IN HER UNTIMELY DEATH, REQUIRING MEDICAL TREATMENT AND CAUSING SIGNIFICANT PAIN, SUFFERING, AND DAMAGES.

    Description of Event or Problem · 0

    ON (B)(6) 2025, OUR CLIENT PASSED AWAY WHILE USING AN OXYGEN TANK THAT WAS MANUFACTURED AND/OR DISTRIBUTED BY YOU, WHEN THE TANK MALFUNCTIONED. THE OXYGEN TANK WAS SUPPLIED BY (B)(4) AND WAS MANUFACTURED BY COMPASS HEALTH BRANDS. AS A RESULT OF THIS DEFECT AND MALFUNCTION, OUR CLIENT PASSED AWAY FROM A RESIDENTIAL FIRE DUE TO THE RECALL OF THE OXYGEN MACHINE PROVIDED WHICH RESULTED IN HER UNTIMELY DEATH, REQUIRING MEDICAL TREATMENT AND CAUSING SIGNIFICANT PAIN, SUFFERING, AND DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236166 TRUAIRE-5 OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD. 1-O2C5L

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death