BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDAIR STANDARD TUBE

    MDR report key: 23257593 · Received October 9, 2025

    Report

    Report Number
    MW5177135
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Report Date
    October 6, 2025
    Manufacturer
    RESMED CORP.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE HUMIDAIR STANDARD TUB PART #37299 SUPPLIED FOR THE RESMED AIRSENSE 10 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MACHINES IS NOT COMPATIBLE AND WILL NOT HEAT. RESMED HAS A NEWER MODEL CPAP MACHINE, THE AIRSENSE 11, AND DISCONTINUED THE OLDER COMPATIBLE TUB PART #39474. PATIENTS PRESCRIBED WITH HUMIFICATION ARE COMPROMISED IN THEIR TREATMENT. RESMED CORPORATION 9001 SPECTRUM CENTER BLVD, SAN DIEGO, CA 92123 +1 (858) 836-5000, +1 (800) 424-0737 (TOLL FREE), FAX: +1 (858) 836-5501, EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301742 HUMIDAIR STANDARD TUBE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORP. 37299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male