BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENTAL, DREAMSTATION ST30, GB

    MDR report key: 21955188 · Received May 2, 2025

    Report

    Report Number
    2518422-2025-105135
    Event Type
    Death
    Date Received
    May 2, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 5, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION ST30 DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION VIA EMAIL TO THE NHS (NATIONAL HEALTH SERVICE) ([email protected]) ON 06/30/2025, 07/03/2025, 07/09/2025. NO RESPONSE WAS RECEIVED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION ST30 DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED. 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
    469517 RENTAL, DREAMSTATION ST30, GB VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. RGBX1030S20 00606959418981

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death