BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS DREAMSTATION 1

    MDR report key: 12130086 · Received July 6, 2021

    Report

    Report Number
    MW5102316
    Event Type
    Injury
    Date Received
    July 6, 2021
    Report Date
    July 1, 2021
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RESTRONIC PHILLIPS DREAMSTATION 1. I HAVE DEVELOPED CHRONIC KIDNEY DISEASE STAGE 3, PNEUMONIA LAST 6 MONTHS, SPOTS ON LUNGS LAST 2 YEARS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021031 PHILLIPS DREAMSTATION 1 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1