BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION ST30

    MDR report key: 24343218 · Received February 16, 2026

    Report

    Report Number
    2518422-2026-101299
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    July 16, 2023
    Report Date
    February 16, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063433
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A REP DREAMSTATION ST30 DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406553 REP DREAMSTATION ST30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1030S11F 00606959063433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death