BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS DREAMSTATION CPAP

    MDR report key: 12293879 · Received August 6, 2021

    Report

    Report Number
    MW5103080
    Event Type
    Injury
    Date Received
    August 6, 2021
    Report Date
    August 4, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE PHILLIPS CPAP MACHINE I HAD SINUS PROBLEMS AND EXTREME NAUSEA EVERY MORNING UNTIL I STOPPED USING THE MACHINE I THINK IT IS STILL AFFECTING MY BREATHING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188658 PHILLIPS DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR