BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP MACHINE

    MDR report key: 12172986 · Received July 14, 2021

    Report

    Report Number
    MW5102534
    Event Type
    Injury
    Date Received
    July 14, 2021
    Report Date
    July 12, 2021
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS USING THE PHILLIPS RESPIRONICS CPAP DREAM STATION FOR 3 YEARS AND JUST GOT NOTIFIED OF A RECALL FOR THE MACHINE. HAVE OFTEN GOTTEN A COUGH AND COOLER AIRWAY IRRITATION WHEN USING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065880 DREAMSTATION AUTO CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR