BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 23767356 · Received December 10, 2025

    Report

    Report Number
    2518422-2025-112467
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    October 28, 2024
    Report Date
    December 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429765
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A REP DREAMSTATION AUTO CPAP HAS PASSED AWAY AND THE PATIENT REPRESENTATIVE IS REQUESTING A SHIPPING LABEL TO RETURN THE DEVICE. 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. DURING THE EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE DEVICE WAS IN GOOD CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877226 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F 00606959429765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death