BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2

    MDR report key: 18312364 · Received December 11, 2023

    Report

    Report Number
    MW5149146
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 19, 2023
    Report Date
    December 8, 2023
    Manufacturer
    PHILLIPS/RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY DREAM STATION 2 STARTED SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304551 DREAMSTATION 2 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other