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

Model Number DSX500T11C

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Nausea (1970); Vertigo (2134); Dizziness (2194)

Event Date 01/11/2021

Event Type  Injury  

Event Description

Several doctor visits; i began feeling vertigo on my right side when i go to sleep at night and when i wake up.I am thinking it is because of the philips respironics cpap dream station i use for my sleep apnea.The vertigo started just with laying on my right side when i roll onto my right side.I have about a 30 second spin and then it stops.Through the night if i go back to my right side in my sleep it occurs again.In (b)(6) my symptoms increased and the week of (b)(6) 2021 i had vertigo on both sides of my head - dizzy and nausea severely and needed to stay in bed for several days.I take bonnine to help but it took several days for the headaches and dizziness to lighten.In (b)(6) i saw my pcp and she administered the epley maneuver which i continued over the next week trying to get the vertigo spin to stop.It never really worked completely.The symptoms subsided on my left side but not my right.She also prescribed an anti-nausea medication to help with the symptoms.Then the nausea, headaches and vertigo came back in (b)(6) and i began the whole process again.In (b)(6) i saw a neurologist who did the epley maneuver 3 times over 2 visits and i still have dizziness on my right side when i lay on that side during sleep and when i wake up in the morning i feel a wave of dizziness.Two weeks ago i learned of the cpap recall and registered my unit.I have been using my older cpap and stopped using the philips brand to see if that is what is causing my symptoms.I do feel my symptoms are improving slightly.I don't know if the cpap is what is causing the vertigo, but i wanted to bring it to your attention.Omt = osteopath manipulation treatment.Appointments with neurologist (b)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12238574
• MDR Text Key: 264055771
• Report Number: MW5102789
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75