BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION ST30

    MDR report key: 21189973 · Received January 20, 2025

    Report

    Report Number
    2518422-2025-005081
    Event Type
    Death
    Date Received
    January 20, 2025
    Date of Event
    May 16, 2022
    Report Date
    January 20, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063433
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF REP DREAMSTATION ST30. THE MANUFACTURER RECEIVED INFORMATION STATING THAT THE PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439465 REP DREAMSTATION ST30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1030S11F 00606959063433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death