BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 12137252 · Received July 7, 2021

    Report

    Report Number
    MW5102373
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 5, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHEST PAIN, CONGESTION, BRONCHITIS, ASTHMA FLARE UPS, CHRONIC COUGH, BREATHLESSNESS, MUCUS, CONTINUED ILLNESS AFTER USING RESPIRONICS DREAMSTATION AT HIGH HUMIDITY LEVELS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022968 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability