BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESSENCE RENTAL WITH SSD

    MDR report key: 20310290 · Received September 26, 2024

    Report

    Report Number
    2518422-2024-59764
    Event Type
    Death
    Date Received
    September 26, 2024
    Date of Event
    August 11, 2022
    Report Date
    September 26, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BTI
    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 RECEIVED INFORMATION REGARDING AN ESSENCE RENTAL. THE PATIENT HAS PASSED AWAY. THE MANUFACTURE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURE'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304252 ESSENCE RENTAL WITH SSD NEBULIZER SYSTEM, NON-HEATED BTI RESPIRONICS, INC. R1112261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death