BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 23025465 · Received September 11, 2025

    Report

    Report Number
    2518422-2025-049194
    Event Type
    Death
    Date Received
    September 11, 2025
    Date of Event
    April 4, 2023
    Report Date
    September 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959063488
    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 AN ISSUE RELATED TO A REP DREAMSTATION AUTO BIPAP DEVICE. THERE WAS REPORT OF PATIENT DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231780 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIR ATOR) BZD RESPIRONICS, INC. DSX700S11F 00606959063488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death