BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 12032287 · Received June 17, 2021

    Report

    Report Number
    MW5101978
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 5, 2000
    Report Date
    June 15, 2021
    Manufacturer
    PHILIPS/ RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING A CPAP FOR MANY MANY YEARS. THIS DREAMSTATION IS ABOUT 2-3 YEARS SLID. I HAVE NOT BEEN FEELING WELL AT ALL AFTER WAKING UP- BAD HEADACHES, WHICH GO IN FOR WEEKS, SINUS ISSUES, HYPERSENSITIVE TO SOUNDS, NAUSEA, SORE THROAT AND EYE AND NOSE IRRITATION MANY DOCTORS VISITS FOR HEADACHES AND MIGRAINES- INCLUDING A THREE DAY INFUSION. I ALSO HAVE COMMON VARIABLE IMMUNE DEFICIENCY, SO I AM VARY CONCERNED ABOUT POTENTIAL CHEMICALS HARMING ME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911190 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS/ RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other