BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS DREAMSTATION

    MDR report key: 12049736 · Received June 22, 2021

    Report

    Report Number
    MW5102031
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 17, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE COUGHING; STARTING IN (B)(6) 2020 I HAD AN COUGH THROUGH OUT THE DAY AND NIGHT, IT HAS INCREASED TO A POINT I HAVE LOST MY VOICE, HAVING SEVERE COUGHING FITS THAT MAKES IT DIFFICULT TO BREATH AND GAGING. I AM VERY WORRIED ABOUT LONG TERM AFFECTS THAT HAVE NOT BEEN DETECTED YET. USED THE DEVICE FOR 3 YEARS AND STARTED GETTING AFFECTS IN (B)(6) 2020 GRADUALLY GOT WORSE AND WAS SEEING A DOCTOR FOR MY HEALTH ISSUES, THEN FOUND OUT ABOUT A RECALL ON (B)(6) 2021. THAT LIST THE EFFECTS I HAVE BEEN HAVING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935755 PHILIPS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other