BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2

    MDR report key: 18809658 · Received February 27, 2024

    Report

    Report Number
    MW5152162
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Report Date
    February 23, 2024
    Manufacturer
    PHILLIPS / 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

    THE REPLACEMENT DREAMSTATION 2 WILL SMELL WHEN THE WATER CHAMBER IS EMPTY. THIS SMELL COMES THROUGH THE TUBING AND NOSE PIECE. IT ALSO GETS VERY HOT WHEN THERE ISN'T ANY WATER IN THE CHAMBER. IT HAS HAPPENED EVER SINCE THEY SENT IT TO ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297162 DREAMSTATION 2 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female HORMONE MEDICATION.| FISH OIL.| MAGNESIUM.| THYROID MEDICATION.