MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAM STATION 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Patient Problems Erythema (1840); Unspecified Respiratory Problem (4464); Eye Infections (4466); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 01/05/2023

Event Type  Injury  

Event Description

I am not sure when i got the new machine but ever since i have noticed increased eye and nose irritation and also around my mouth.My eyes are swelling and have become infected.I wake up in the morning with them swelled and very dry and matted.My nose has become stopped up almost constantly making me breath thru my mouth.The new machine is worse than the old one.I have never had a problem breaking out around my mouth either.But right where that mask sits is red itchy and irritated and i have to keep cortisone cream and right between my eyes where the air blows out.This is what is causing all the eyes, nose and mouth irritation and infection.

• Brand Name: DREAM STATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18704413
• MDR Text Key: 335461735
• Report Number: MW5151580
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 006069659062733
• UDI-Public: (01)006069659062733
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Patient Sequence Number: 1
• Treatment: AMBIEN; AMLODIPINE ; ASPIRIN ; ASPIRIN ; ATORVASTATIN ; B12 INJECTION ; BUSPIRONE ; FLEXIRIL ; HYDROCODONE; HYDROXYZINE; IBUPROFEN 800; LYRICA; MINOXIDIL ; NORTRIPTYLINE; ROPINIROLE; TOPAMAX ; TRAZODONE
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White