BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2 AUTO CPAP ADVANCED

    MDR report key: 18798597 · Received February 27, 2024

    Report

    Report Number
    MW5152063
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 21, 2024
    Report Date
    February 14, 2024
    Manufacturer
    PHILLIPS/RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959062733
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN THE MORNING AFTER SLEEPING ALL NIGHT WITH MY PHILLIPS DREAMSTATION 2 CPAP MACHINE, I STARTED NOTICING A BURNING SMELL COMING THROUGH THE MASK ON MY MACHINE. I CHECKED THE HUMIDIFIER TO ENSURE I HAD NOT RUN OUT OF WATER AND IT WAS HALF FULL. THERE IS NO PHYSICAL DAMAGE EVIDENT ON THE OUTSIDE OF THE MACHINE SO I TRIED THE CPAP MACHINE THE NEXT NIGHT WITH A FULL HUMIDIFIER TANK. THE NEXT MORNING AS I WAS WAKING UP I NOTICED THE SAME SMELL OF BURNING ELECTRONICS COMING THROUGH MY MASK. AFTER A QUICK GOOGLE SEARCH I FOUND THE FDA WARNING ON THE DREAMSTATION 2 FROM (B)(6) 2023. I DISCONTINUED USE OF MY CPAP MACHINE AND SWITCHED TO MY BACKUP DENTAL APPLIANCE. I HAVE NOTIFIED PHILIPS OF THIS ISSUE AND RECEIVED THE REF (B)(4) FOR MY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451674 DREAMSTATION 2 AUTO CPAP ADVANCED VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS/RESPIRONICS INC DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other FLONASE.| ZYRTEC.