MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS RESPIRONIC DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US

Device Problem Material Discolored (1170)

Patient Problems Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Unspecified Eye / Vision Problem (4471); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

I have been having lots of different health problems internally and externally including worsening asthma, allergies, lots of skin and eye irritation, and also headaches and nausea.I've been using the philips respironic dreamstation for at least the last 4-5 years.For awhile now there has been a lot of discolored dust or powder that has been forming in all parts of my cpap machine daily.I am going to quit the use of it starting today and i will inform my primary physician to figure out what i need to do from here.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONIC DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 13619011
• MDR Text Key: 286349018
• Report Number: MW5107751
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025646
• UDI-Public: (01)00606959025646
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DreamStation Auto CPAP w/Humid, w/H Tube, w/Cell, US
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; CBD ; CETIRIZINE HYDROCHLORIDE TABLETS; VITAMIN C; VITAMIN D3; ZINC
• Patient Outcome(s): Disability
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White