BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 20328761 · Received September 28, 2024

    Report

    Report Number
    3014810929-2024-00002
    Event Type
    Malfunction
    Date Received
    September 28, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 20, 2024
    Manufacturer
    JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD
    Product Code
    CAW
    UDI-DI
    00092237623152
    PMA / PMN Number
    K090007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CANNOT DETERMINE THE CAUSE OF THE EVENT ON THE BASIS OF INFORMATION THUS FAR AVAILABLE. THE MANUFACTURER CONTINUES TO REQUEST RETURN OF THE DEVICE FOR FURTHER ANALYSIS. THE MANUFACTURER HAS CONDUCTED INDEPENDENT ELECTRICAL TESTING ON A DEVICE FROM A PROXIMAL LOT AND MONTH, SN (B)(6) (LOT# JA2311, MANUFACTURE DATE: NOVEMBER 24, 2023), AND FOUND THE DEVICE MET ELECTRICAL STANDARDS.

    Description of Event or Problem · 0

    A CONCENTRATOR CAUGHT ON FIRE IN A PATIENT'S BATHROOM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. THE MANUFACTURER CONTINUES TO REQUEST THE RETURN OF THE DEVICE FOR FURTHER ANALYSIS. IT SHOULD BE NOTED THAT THE MANUFACTURER HAS CONDUCTED INDEPENDENT ELECTRICAL TESTING ON A DEVICE FROM A PROXIMAL LOT AND MONTH, (B)(6) (LOT# JA2311, MANUFACTURE DATE: NOVEMBER 24, 2023), AND DETERMINED THE DEVICE TO MEET ELECTRICAL STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602502 COMPASS HEALTH BRANDS TRUAIRE 5 O2 CONCENTRATOR CAW JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD O2C5L JA2312 00092237623152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other