BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 14137843 · Received April 15, 2022

    Report

    Report Number
    MW5109138
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    August 16, 2021
    Report Date
    April 14, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING A TWO-WEEK TIME PERIOD, I BEGAN EXPERIENCING DYSPNOEA AND DIZZINESS WHILE DOING REPAIRS TO RENTAL HOME UPSTAIRS, AS WELL AS A HARSH DRY COUGH. TESTED NEGATIVE FOR COVID-19. PRIMARY PHYSICIAN SWITCHED MY BLOOD PRESSURE MEDICINE AND THE DRY COUGH STOPPED IN SEPTEMBER. BREATHLESSNESS CONTINUED UPON MILD EXERTION. I WAS NOT NOTIFIED ABOUT DREAMSTATION RECALL. SAW CARDIOLOGIST ON (B)(6) FOR THE FIRST TIME, TESTS WERE SCHEDULED, INCLUDING HRCT, WHICH THEN SHOWED ACUTE OR CHRONIC ILD. NON-SMOKER, NO FAMILY HISTORY OF RESPIRATORY ILLNESSES, CONSIDERED IPF AND WILL HAVE PFTS IN (B)(6) 2022 TO SEE IF FIBROSIS HAS PROGRESSED. FOUND OUT ABOUT RECALL IN LATE (B)(6) 2022, FROM (B)(6) NEWS HEADLINE. STOPPED USING AND SEALED UP DREAMSTATION, REGISTERED ON PHILIPS WEBSITE. WOULD LIKE THE MACHINE TESTED TO CONFIRM CAUSE OF ILD. BEGAN OXYGEN 24/7 IN (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493633 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. REF: DSX500H11C 2016-09-30

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Disability BLOOD GLUCOSE MONITOR KIT| CPAP | D3 GUMMIES| FENOFIBRATE| LEVOTHYROXINE| LOSARTAN | METFORMIN | NATUREMADE EXTRA STRENGTH | NORTRIPTYLINE| NOVOLOG FLEXPEN| OXYGEN CONCENTRATOR | RESOVASTATIN| TRULICITY| VITAFUSION WOMEN'S MULTI