BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENTAL, DREAMSTATION ST30, GB

    MDR report key: 21664875 · Received March 21, 2025

    Report

    Report Number
    2518422-2025-103286
    Event Type
    Death
    Date Received
    March 21, 2025
    Date of Event
    March 19, 2025
    Report Date
    December 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959418981
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE THREE GOOD FAITH-EFFORT ATTEMPTS ON 06/03/2025 TO (B)(6), AND TWO ATTEMPTS ON 12/06/2025 AND 12/11/2025 TO (B)(6), THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE COMPLETED. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RENTAL DREAMSTATION ST30 DEVICE WAS BEING RETURNED DUE TO THE USER PASSING AWAY. THERE WAS NO ALLEGATION OF MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. THERE WERE NO REPORTS OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION IS BEING REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901121 RENTAL, DREAMSTATION ST30, GB VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. RGBX1030S20 00606959418981

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death