BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAM STATION 2 CPAP MACHINE

    MDR report key: 16254094 · Received January 26, 2023

    Report

    Report Number
    MW5114535
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 24, 2023
    Manufacturer
    PHILLIPS/RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE USING MY CPAP MACHINE I WOKE UP IN THE MIDDLE OF THE NIGHT CHOKING AND TOOK OFF THE FACE MASK. I COULD SMELL A HORRIBLE BURNING PLASTIC ODOR. I HAVE BEEN USING THIS MACHINE SINCE (B)(6) 2021 WITHOUT ANY PROBLEMS. WHEN I BROUGHT IT TO THE SUPPLIER THEY REPLACED IT WITH THE SAME MODEL. 2 DAYS AFTER THE INCIDENT I DEVELOPED BRONCHITIS. I WAS TREATED AT AN OUTPATIENT URGENT CARE AND TOOK TWO WEEKS TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925142 DREAM STATION 2 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS INC.
    925143 DREAM STATION 2 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other METOPROLOL, TERAZOSIN, BENAZEPRIL, ALLOPURINOL, K+, LASIX, MESALAMINE.| RED YEAST RICE, FISH OIL, MULTIVITAMIN WITH MINERALS, CALCIUM WITH VIT D, VITAMIN D, GLUCOSAMINE CHONDROITIN, B12.