BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATIONSTNAUTOCPAPHUMCELL DOM DREAMSTATION STN AUTO CPAP HUM CELL DOM

    MDR report key: 12203092 · Received July 20, 2021

    Report

    Report Number
    MW5102659
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 17, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959025639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HARSH COUGH NONPRODUCTIVE, COARSE VOICE, INABILITY TO CLEAR THROAT FROM MUCUS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093402 DREAMSTATIONSTNAUTOCPAPHUMCELL DOM DREAMSTATION STN AUTO CPAP HUM CELL DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC DreamStation Auto CPAP w/Humidifier, w/Cell, US 00606959025639

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability