BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION RESPIRONICS

    MDR report key: 12099236 · Received June 30, 2021

    Report

    Report Number
    MW5102217
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    March 28, 2018
    Report Date
    June 26, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED USING THE DREAMSTATION CPAP MACHINE IN (B)(6) 2017. FROM THEN UNTIL LAST WEEK I WOULD WAKE UP IN THE MORNINGS WITH THROAT AND NASAL IRRITATION VERY OFTEN. I'M (B)(6) 2018 I WAS DIAGNOSED WITH NON-SMALL CELL LUNG CANCER/LARGE CELL AND AM FIGHTING IT STILL. I WAS TOLD IT IS A VERY RARE STRAIN AND THERE'S NO CURE FOR IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989617 DREAMSTATION RESPIRONICS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| S