BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS DREAMSTATION

    MDR report key: 13584484 · Received February 22, 2022

    Report

    Report Number
    MW5107640
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    June 1, 2021
    Report Date
    February 18, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I FOUND OUT THAT MY CPAP WAS RELEASING CARCINOGENS FROM THE FOAM INSIDE. FDA SAFETY REPORT ID #:(B)(4).

    Description of Event or Problem · 0

    I FOUND OUT THAT MY CPAP WAS RELEASING CARCINOGENS FROM THE FOAM INSIDE. FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944189 PHILIPS RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DREAM STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Life Threatening