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

Device Problems Material Discolored (1170); Nonstandard Device (1420); Noise, Audible (3273)

Patient Problems Dyspnea (1816); Headache (1880); Nausea (1970); Skin Discoloration (2074); Vertigo (2134); Unspecified Eye / Vision Problem (4471); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Philips respironics dreamstation purchased 7/14/2017 began making strange noises summer of 2021.Filters became blackened, dark grey.Noise stopped, filters still darker than normal, changed more often.I thought it was air quality in house, allergies.Experienced headaches, nausea, some occasional vertigo, eyes irritated, skin on face red, swollen.Heavy chest, increased shortness of breath.Afib worsened.Had heart ablation in (b)(6) 2021.Confirmed machine was on recall list 11/12/2021 and registered with philips.Am to use even when napping, plus nights.Have stopped use until i can discuss with doctor.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12829001
• MDR Text Key: 280954911
• Report Number: MW5105379
• Device Sequence Number: 1
• Product Code: BZD
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL RESCUE INHALER; BENADRYL AS NEEDED; ELIQUIS; EPI PEN; FLECAINIDE (POCKET PILL); FUROSEMIDE; LOSARTAN; METOPROLOL; POT CHLORIDE; VITAMIN D3; ZYRTEC AS NEEDED
• Patient Outcome(s): Disability
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White