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

Device Problems Nonstandard Device (1420); Particulates (1451)

Patient Problems Asthma (1726); Cough (4457); Skin Inflammation/ Irritation (4545)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Both of my philips repironics dreamstations that i have used for the past 5 years were included in the recall.I experienced sinus issues and a morning cough the entire time i used my philips cpap machines, but just attributed it to allergies.I did notice black "dust" when i cleaned my machine now and then (i never used an ozone cleaner).I replaced my old dreamstation cpap machine in (b)(6) 2021 with a new one.I suddenly developed severe asthma symptoms that required the use of an inhaler to get under control.I haven't had asthma like that since i was (b)(6) and i'm (b)(6).I assumed i was having an allergic reaction to something (although nothing in our home had changed) or it was due to poor air quality, but as soon as i got the recall notice and registered my devices (both my previous machine and my new machine were impacted) i coordinated with my dme company and insurance and got a replacement resmed machine on (b)(6) 2021.My asthma and sinus symptoms resolved within a week.I thought it was odd that my new 2021 machine caused more issues immediately after beginning use than my old machine had caused over a 3 year period.My old machine did cause lung and sinus irritation just not to the extent the new machine did.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13207584
• MDR Text Key: 283666885
• Report Number: MW5106555
• 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: 01/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/07/2022
• Patient Sequence Number: 1
• Treatment: MOUTH MASK; RESMED CPAP MACHINE WITH FULL NOSE
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White