BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION BIPAP AUTOSV

    MDR report key: 23770966 · Received December 10, 2025

    Report

    Report Number
    2518422-2025-058931
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    July 5, 2023
    Report Date
    December 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063495
    PMA / PMN Number
    K090539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A REP DREAMSTATION BIPAP AUTOSV DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107281 REP DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900S11F 00606959063495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death