BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP

    MDR report key: 12180394 · Received July 15, 2021

    Report

    Report Number
    MW5102563
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    November 25, 2019
    Report Date
    July 13, 2021
    Manufacturer
    PHILLIPS RESPIRONICS INC
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED MY PHILLIPS DREAM STATION CPAP THE BEGINNING OF (B)(6) 2019. BY THANKSGIVING OF THAT YEAR I HAD MY FIRST BOUT OF BRONCHITIS. I RECOVERED FROM THE BRONCHITIS AFTER ANTIBIOTIC THERAPY BUT I HAVE CONTINUED TO HAVE A COUGH EVER SINCE. ABOUT 6 MONTHS LATER I HAD A CHEST X-RAY WHICH WAS NEGATIVE. MY ALLERGIES SEEM TO BE WORSE I HAVE A LOT OF SINUS CONGESTION. I SWITCHED ALLERGY MEDICATION. SINCE COVID-19 LOCKDOWN IN (B)(6) OF 2020 I HAVE HAD TWO COLDS ONE INCLUDED A SINUS INFECTION. I TESTED NEGATIVE FOR COVID 19. I STOPPED USING MY CPAP AND CONTACTED MY DOCTOR. SINCE I HAD NEVER USED THE SO CLEAN DEVICE I WAS ADVISED THAT IT WAS OKAY TO CONTINUE USING THE PHILLIPS BUT BASED ON MY INCREASED SYMPTOMS I AM RELUCTANT TO DO SO. I REGISTERED MY DEVICE THROUGH THE PHILIPS WEBSITE AND WAS ADVISED THAT I COULD BUY ANOTHER CPAP MACHINE OUTRIGHT FROM MY DME. MY MACHINE IS UNDER 2 YEARS OLD THEREFORE UNDER WARRANTY I FEEL AS THOUGH I SHOULD GET A REFUND. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075040 CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Disability