MAUDE Adverse Event Report: RESMED CORP. RESMED AIRCURVE 10 VAUTO CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DN 703

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Sore Throat (2396); Ambulation Difficulties (2544); Weight Changes (2607); Eye Infections (4466); Swelling/ Edema (4577)

Event Date 10/09/2019

Event Type  Injury  

Event Description

I was experiencing facial and eye swelling; bacterial eye infections, fatigue; severe headache, severe sore throat; body pain to the point it was painful to move; difficulty dressing myself; getting in/out of bed; just moving in general; the facial /eye swelling was very severe and progressively getting worse over a 2-year period.I have been using cpap for 15 years.During that time i have experienced a variety of symptoms that were determined "unexplained".(b)(6) 2018 i was diagnosed with a sinus infection; (b)(6) 2018 i started getting eye infections.Over the next several months i would experience severe headache, severe sore throat, then my eye would swell to the point i looked like i was in a-boxing match and lost.I would be put on antibiotic and the swelling would decrease but "swelling/puffiness of my eye-upper and lower lids" and my face always was swollen.Doctors would tell me that the bags under my eyes were "my age" and it was an allergy.During this 2+ year time period i went to over 30 doctors trying to figure out what was causing this problem; 12 eye doctors (3 of them ocular plastic surgeons), neurologist, 4 allergists; 4 ent's; rheumatologist; endocrinologists; cardiologists, pulmonologist, dermatologist; infectious disease doctor, 2 dentists.The swelling was getting worse the fall of 2020.I had exhausted all my efforts.Although i did find scientific articles regarding reactions to silicone which is what the mask are made from and also silicone is used "inside" the resmed cpap machines.In (b)(6) 2020 i decided to stop using the cpap machine because that was the one thing i did not try and no doctor would admit that could be causing the problem.Within weeks i could see the swelling going from my face and eyes and within a month my body pain was gone.It has taken 6+ months for my body to return to normal.I have lost weight because i don't have air pumped into my body.One doctor told me i was looking like a "chipmunk" because i had gotten to puffy.I will neve return-to using cpap again.It has been destructive for me.All the symptoms it was suppose to cure were exacerbated for me.

• Brand Name: RESMED AIRCURVE 10 VAUTO CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 12513278
• MDR Text Key: 273090606
• Report Number: MW5104142
• 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: 09/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DN 703
• Device Catalogue Number: R370-4123/1
• Device Lot Number: 1393582
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 72 YR
• Patient Weight: 70