BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION

    MDR report key: 23465943 · Received November 4, 2025

    Report

    Report Number
    2518422-2025-111580
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    March 13, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424739
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY SUBMITTED REPORT HAS RECALL NUMBER MENTIONED INCORRECTLY, IN THIS REPORT, SECTION H "RECALL (Z) NUMBER" HAS BEEN CORRECTED/UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-111015. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    Description of Event or Problem · 0

    A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO THE SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777110 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. INX500S15 00606959424739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown