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

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

Patient Problems Inflammation (1932); Pain (1994); Sneezing (2251); Sore Throat (2396); Unspecified Heart Problem (4454); Cough (4457); Epistaxis (4458); Unspecified Respiratory Problem (4464)

Event Date 08/04/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 i began sneezing, then on (b)(6) 2021 i began coughing.On (b)(6) 2021 i started to get a sore throat.I felt it would go away, but it the sore throat only got worse, so on (b)(6) 2021 i went to an urgent care at (b)(6).The dr said i was extremely inflamed in my nasal passages, throat and ears and thought i presented with symptom of covid-19 and/or strep throat so they tested me for both conditions.I was negative for both conditions and she told me to start to use flonase for 10 days and salt water rinses and drink a lot of liquids and rest.I stopped using the flonase by weaning off of it per my allergist and she prescribed azelatin nasal spray to dry me up but i became very dry so i started using ayr nasal gel spray with moisturizers and that helped with the problem.On (b)(6) 2021 i stopped using the machine because on (b)(6) 2021 i found out that philips respironics had recalled cpap and bipap machines by a pop up news article on my cell phone.I called my sleep dr 1 week later to tell him that i stopped using it, but i had to wait until my (b)(6) 2021 appt to discuss this with him.In the meantime on (b)(6) 2021 i developed jaw pain.I had an x ray of my mandible done on (b)(6) 2021 to see if i had osteonecrosis of the jaw since i had restarted taking actonel this past year, after taking a vacation from it for 10 years.Prior to that i had been taking actonel for approx 7 years.I had dental x-ray done on (b)(6) 2021 and saw my periodontist on (b)(6) 2021 who also did x-rays of my jaw to check the dental implant.All was good with my implant and jaw bone according to the all of the x rays i had done during that past week.My periodontist suggested pt for my jaw pain so i did 5 sessions of pt ending the last day of (b)(6).The pt helped.My sleep dr.Recommended i restart using the bipap machine on (b)(6) because in (b)(6) i began experiencing heart racing episodes waking me up at 2, 3 or 5 a.M.Every morning.My pulmonologist ordered a holter monitor for me to wear for 2 weeks.I took it off on (b)(6) 2021 and mailed it back to the company to obtain results.I will be getting an echocardiogram on (b)(6) 2021.I am using the machine without the humidifier and a special bacterial filter currently and it is causing me to have a very stuffy nose, bleeding nasal passages at times and sneezing.I am afraid to use the humidifier with the machine, so i have been running a humidifier in my bedroom.It helps a little with the stuffy nose and bleeding, but i sneeze during the nights while sleeping and when i wake up.I miss not using the humidifier attachment and my jaw is beginning to hurt so i just continue to do my daily pt exercises.I cannot wait for philips to get me my new machine.I am constantly experiencing very stuffy nose throughout the day.I can obtain medical records if necessary.I have sleep dr appt on (b)(6) 2021 and allergy dr appts on (b)(6) 2021 and (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12934190
• MDR Text Key: 281879054
• Report Number: MW5105808
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/01/2021
• 2 Devices were Involved in the Event: 1 2

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: 12/03/2021
• Patient Sequence Number: 1
• Treatment: ALBUTEROL INHALER AND IN NEBULIZER; AMLODIPINE BESYLATE; ATORVASTATIN; AYR; B-12; BREO; CALTRATE; CITRICAL; CVS NASAL SPRAY; DEPOMEDROL SHOTS IN KNEE 2X/YEAR; FLONASE IF NEEDED; MELOXICAM; OSTEOARTHRITIS BIFLEX; SUPARTZ 2X/YEAR; UNITHROID; WOMEN'S MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White