BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION ST30

    MDR report key: 21218882 · Received January 23, 2025

    Report

    Report Number
    2518422-2025-101113
    Event Type
    Death
    Date Received
    January 23, 2025
    Date of Event
    September 1, 2023
    Report Date
    September 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063433
    PMA / PMN Number
    K102465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION THAT A PATIENT WITH A REP DREAMSTATION ST30 DEVICE PASSED AWAY IN (B)(6) 2023, AND THE PATIENT'S SON WANTED TO RETURN THE REPLACEMENT DEVICE HE RECEIVED FOR HIS FATHER AS IT WAS NOT NEEDED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. THERE WAS NO VALID COMPLAINT TO BE REPRODUCED. NO DEVICE PROBLEM WAS FOUND. THE DEVICE WAS SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. THE MANUFACTURER HAS UPDATED SECTION H IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A REP DREAMSTATION ST30 DEVICE PASSED AWAY IN (B)(6) 2023, AND THE PATIENT'S SON WANTED TO RETURN THE REPLACEMENT DEVICE HE RECEIVED FOR HIS FATHER AS IT IS NOT NEEDED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084354 REP DREAMSTATION ST30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1030S11F 00606959063433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death