MAUDE Adverse Event Report: RESPIRONICS, INC SYSTEM ONE REMSTAR AUTO A-FLEX; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Inflammation (1932); Visual Disturbances (2140); Cough (4457); Wheezing (4463); Unspecified Respiratory Problem (4464)

Event Date 05/16/2022

Event Type  Injury  

Event Description

I have continued using my philips respironics system one series 60 c-pap machine because i have not yet received a replacement or compensation for the five devices i registered (i have homes in (b)(6), (b)(6) and keep machines in all three homes).I have developed a wheezing and a frequent cough that is concerning me.I have just recently returned from the (b)(6) and haven't been able to find a new pulmonologist (my previous one retired while i was away).I suffer from autoimmune issues that are possibly being made worse if there are any particles being inhaled from my c-pap machine.My overall inflammation has also become worse over the last several months, which sometimes happens when i am exposed to an irritating inhalant.I have also developed vision issues (a light crescent rolling from the outside edge of the field of vision downwards) and have experienced sinus pressure and headaches as well.Are these symptoms of the kind of health issues caused by these faulty c-pap machines? fda safety report id # (b)(4).

• Brand Name: SYSTEM ONE REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC
• MDR Report Key: 15894412
• MDR Text Key: 304740462
• Report Number: MW5113561
• Device Sequence Number: 3
• Product Code: MNS
• 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: 11/28/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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
• Patient Sequence Number: 1
• Treatment: COZAAR/HYZAAR, SYNTHROID, RABEPRAZOLE. CANE OR WALKER AS NEEDED.; VITAMIN D3, EXTRA STRENGTH TYLENOL AND/OR ALEVE AS NEEDED FOR PAIN.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White