BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 19625158 · Received June 27, 2024

    Report

    Report Number
    2518422-2024-40099
    Event Type
    Death
    Date Received
    June 27, 2024
    Date of Event
    February 17, 2023
    Report Date
    June 27, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    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 WAS CONTACTED IN REFERENCE TO A REP DREAMSTATION AUTO CPAP. THE PATIENT PASSED AWAY. 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
    1751339 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death