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

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Apnea (1720); Chest Pain (1776); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Eye Infections (4466)

Event Type  Injury  

Event Description

User of dreamstatiom cpap machine that was recalled.Within the past 1-2 years, i have suffered from severe consistent headaches and fatigue as well as mild chest pressure.Also, i experienced a severe eye infection that lasted approximately a week.Consultation with rheumatologist indicated inflammation and i am in contact with my doctor to address these issues.I have discontinued use of the product per the instructions of the recall.I have severe sleep apnea and discontinued use is affecting my quality of life.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP HUM DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12814696
• MDR Text Key: 280911598
• Report Number: MW5105321
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; BIOTIN; COENZYME Q-TIN; LEXAPRO; MELATONIN; METFORMIN; METHYLPHENIDATE; MULTIVITAMIN; OMEGA 3; SPIRONOLACTONE; TURMERIC; VITAMIN C; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White