BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAM STATION CPAP

    MDR report key: 12180418 · Received July 15, 2021

    Report

    Report Number
    MW5102566
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    January 1, 2020
    Report Date
    July 13, 2021
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS PRESCRIBED THE CPAP DREAM STATION (B)(6) 2019. INITIALLY, THE DEVICE SEEMED TO BE THE ANECDOTE FOR MY DIAGNOSED SLEEP APNEA. ALTHOUGH, I FOLLOWED THE PRECISE GUIDELINES IN THE MAINTENANCE AND CARE OF THE DREAM STATION, I BEGAN TO EXPERIENCE CONSTANT DRY IRRITATION IN MY UPPER RESPIRATORY AREA AND DRY COUGH. THESE SYMPTOMS BEGAN APPROXIMATELY WITHIN A YEAR OF MY USAGE OF THE DEVICE. I WOULD OFTEN AWAKE THROUGH THE NIGHT AND MORNING WITH AN IRRITATED THROAT AND SOMETIMES UNCONTROLLABLE COUGHING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075044 DREAM STATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other