BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 22923243 · Received August 29, 2025

    Report

    Report Number
    2518422-2025-109510
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 29, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959424371
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1972-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A DREAMSTATION BIPAP AUTOSV H/HT, DS DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED AN ERROR CODE PRESENT, SD CARD FOUND, AND SERVICE IS REQUIRED. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2870755 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11 00606959424371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown