BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 12225352 · Received July 23, 2021

    Report

    Report Number
    MW5102746
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 21, 2021
    Manufacturer
    PHILLIPS-RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD BEEN USING DREAMSTATION CPAP FOR ABOUT SIX MONTHS. AT FIRST IT WAS QUITE HELPFUL; I FELT BETTER RESTED DURING THE DAY. ABOUT A MONTH AGO, I COULD SENSE TOXIC FUMES IN MY AIRWAY AND LUNGS WHICH IS LIKELY FROM THE SOUND ABATING FOAM DUE TO THE RECALL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118511 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS-RESPIRONICS, INC. DREAMSTNAUTOCPAPHUMHTCELL DOM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R