BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS REM STAR PRO M-SERIES HEATED HUMIDIFIER

    MDR report key: 23256667 · Received October 9, 2025

    Report

    Report Number
    MW5177128
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    July 26, 2025
    Report Date
    October 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FIRST NOTICED IN EARLY (B)(6) 2025, A BURNING METALLIC SMELL FROM THE CPAP MACHINE. ON J(B)(6) 2025, SMALL BLACK PARTICLES WERE FOUND FLOATING IN THE HUMIDIFIER WATER TANK OF THE M-SERIES HEATED HUMIDIFIER DEVICE MODEL #1051158.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301736 RESPIRONICS REM STAR PRO M-SERIES HEATED HUMIDIFIER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Disability