BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESSENCE WITH SSD

    MDR report key: 20306276 · Received September 25, 2024

    Report

    Report Number
    2518422-2024-59658
    Event Type
    Death
    Date Received
    September 25, 2024
    Date of Event
    June 7, 2022
    Report Date
    September 25, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BTI
    UDI-DI
    00383730001951
    PMA / PMN Number
    K042655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN ESSENCE DEVICE. THERE WAS AN ALLEGATION OF PATIENT PASSING 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
    1199249 ESSENCE WITH SSD NEBULIZER SYSTEM, NON-HEATED BTI RESPIRONICS, INC. 1112261 00383730001951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death