BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K090539

    MDR report key: 24457570 · Received February 26, 2026

    Report

    Report Number
    2518422-2026-006727
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    December 30, 2025
    Report Date
    February 26, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959012523
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1973-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    505

    Narratives

    Description of Event or Problem · 0

    A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE DEVICE EVALUATION, THE SERVICE TECHNICIAN NOTED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED FLUIDS FAIL CONTAMINATION AND UNRELATED ERROR CODES, WHICH ARE CONSISTENT WITH NORMAL DEVICE OPERATION UNDER EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524754 K090539 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS960HS 00606959012523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown