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

Model Number DN956

Patient Problems Headache (1880); Memory Loss/Impairment (1958)

Event Date 03/15/2023

Event Type  Injury  

Event Description

Early this year 2023 i was given new mask equipment from (b)(4) medical group cpap part of clinic (health partners).It was an res med airfit f20 lge - amer ref 63402.I had went in for a yearly check i believe.Soon after i got this, i noticed that i was getting headaches almost every morning then every morning.Also, my memory became "extremely" poor.(i used to be able to do 3 digit addition subtraction, not anymore.Still) i did go to see my regular doctor later as i wanted help; he is a good guy but jokingly laughed and said i remembered to get there.We do joke around alot.I dont think there was anything he could really do at that time but i had too.So that night i cut out one of the rubber valves in the elbow between the hose and the mask.I thought this might help as it seems to stop air from coming up the hose and out the mask on exhale.In other words when i would exhale alot of the oxygen depleted air from my lungs would go into tube and then when i would inhale part would go back into lungs and ruber valves stayed sealed.(ps i am a hvac service tech sales operator owner.Not a scientist, but i know alot about airflow.) immediately the next morning i felt better and within a couple weeks i was back to as i was before except my brain functions and memory.Which are still not as they were before.I "didn't" call anybody immediately as i wanted to get another mask with bad style elbow.And i couldn¿t get one until 6 mos later as 1.Insurance "wouldn't" give another 2.I "couldn¿t" pay for one outside of insurance 3.I "couldn¿t" afford as i was and basically still only making $(b)(6) hr 51 hrs a week.( business people are so rich, lol ) any way, i finally got one (b)(6) 23 as i finally remembered to call.To my amazement it appears to be the same.I have both and still using one i cut valve out of.If you want /need more date and # info we should be able to get it from clinic i cannot remember exact dates.Although this is a goofy cpap machine.Res med device # 956 ser (b)(6), ref 39485, lot 1648947 it automatically adjusts to breathing cycle or something? and i think that is also part of why valves "wouldn't" open to keep fresh air moving through hose as i "doesn't" give enough pressure at inhale and exhale cycles.I still get headaches 10 days a month but that is back to normal for years.I dont want to sue for big money i only want somebody to be held somehow accountable, and at least test these things before throwing them on the public.I truly believe some people may have possibly died from this, as my health was dwindling.Had i not had skills in mechanical problem solving, i wonder if doctors would have been able to find the issue.??? these machines/devices should be tested together before use, not on involuntary patience.Reference report: mw5147711.

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 18065200
• MDR Text Key: 327589630
• Report Number: MW5147712
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DN956
• Device Catalogue Number: 39485
• Device Lot Number: 1648947
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DAILY FIBER METAMUCIL.; DAILY FIBER SUPPLEMENT.; ESCITALOPRAM 20MG.; MENS PLUS 50 MULTI VITAMIN.; SUMATRIPTAN 50MG.
• Patient Outcome(s): Required Intervention; Life Threatening; Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White