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

Device Problem Nonstandard Device (1420)

Patient Problems Bacterial Infection (1735); Headache (1880); Pain (1994); Blurred Vision (2137); Visual Disturbances (2140); Burning Sensation (2146); Dizziness (2194); Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 10/19/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 i received from the (b)(6) hospital the cpap machine philips respironics dreamstation, and accessory equipment such as mask, tubing, and filters.I started using this machine as instructed by my doctor.On (b)(6) 2019 i visited the (b)(6) hospital, primary care unit to get re-evaluated because i was having frequent nasal allergies while using the philips cpap machine.I have several complaints about this on my (b)(6) record.On (b)(6) 2020 i visited the (b)(6) hospital emergency room because "i had a sudden sharp pain in my head, severe headache, and lightheadedness (dizziness)".I was diagnosed with otitis media (middle ears infection/inflammation).Medications were prescribed.On (b)(6) 2020 i visited the (b)(6) hospital emergency room because i was "seeing brightly colored moving lights in his bilateral peripheral fields of vision with slightly blurred vision".I was diagnosed with "visual disturbance".On (b)(6) 2020 i was seen by the (b)(6) hospital sleep clinic to resolve problems because i was still "having nasal congestion with my nasal mask" and "waking up with a frequent sore throat".I requested a full face mask hoping for improvement.On (b)(6) 2020 i was assessed by the (b)(6) hospital tele-care unit to report i was "having frequent headaches and facial burning.Also request testing for the covid 19 virus".Nasal congestion was also reported.I thought i had covid-19 but i did not.The medical assessment was sinusitis.On (b)(6) 2021 i was assessed by the (b)(6) hospital tele-care unit because i was having "headache, severe to moderate".I was screened for covid-19 with a negative result.Medication plan was prescribed.On (b)(6) i received an email from philips.Com, it was a recall notice.On their verification system my machine came as "affected".I learned the health risks on this machine, so i stopped using this machine.I want share my symptoms with the fda.Fda safety report id # (b)(4).

• Brand Name: PHILIPS CPAP MACHINE DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS \ RESPIRONICS, INC.
• MDR Report Key: 13394918
• MDR Text Key: 284822385
• Report Number: MW5107078
• 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: 01/26/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2022
• Patient Sequence Number: 1
• Treatment: ROSUVASTATIN; ZYRTEC
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White