MAUDE Adverse Event Report: RESMED LTD. RES MED AIRSENSE 10 AUTOSET CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number MODEL 10 AUTOSET

Device Problems Device Emits Odor (1425); Defective Device (2588); Output Problem (3005)

Patient Problems Headache (1880); Cognitive Changes (2551); Chemical Exposure (2570); Balance Problems (4401); Cough (4457)

Event Date 12/04/2023

Event Type  Injury  

Event Description

October 16th, 2023 i am a cpap user and have been for 2 decades now.I was issued a new cpap machine, a res med airsense model 11 on (b)(6) 2023.I used the machine once the night of (b)(6) 2023 and woke smelling toxic fumes through the face mask.I had a splitting headache, cognition and balance problems and coughed for two weeks.The fumes smelled like airplane glue.I the contacted a lab in (b)(6) and described what i was smelling and they suggested i perform an air "solvent panel scan." so i procured the equipment and hired a tester to run the tests.The machine is emitting above safe levels of: naphthalene and nitrobenzene.And just under the safe limits for all 60 solvents tested with the scan.The control group showed zero for all 60 solvents.So, i assumed the device was actually used and or defective so i returned the device for a new one with the attached lab results so the dme would not reissue this "used and or defective" device.I was given a new res med airsense model 11 (still in the box) on (b)(6) 2023 when i went into the local lincare office to turn in the "defective" model and receive the new replacement.I turned on the new, replacement machine and the air coming out smelled just like the last one issued-toxic air that smelled like airplane glue.Both new machines are defective and emitting fumes so i googled "off gassing from res med model 11 cpap" and it took me to the "apnea board" chat room for cpap users.I found many people complaining of the same thing and returning their units for older models that did not emit toxins.The gases that are being emitted from these units are known carcinogens and worse and are not passively entering cpap users lungs.The fumes are pumped directly into peoples' respiratory systems through the positive pressure devices -cpap and bipap machines.There is no "rolling down the windows" as in a new car and no indication the fumes discontinue after awhile.I ran my machine-on it's own for many hours and still it smelled just as toxic as when i first turned it on.There are tens of thousands and maybe even millions of people using this defective model machine without knowing the results of these tests.I am writing you today because i was told you have the authority to investigate and ultimately recall this dangerous product to safeguard general public against this hazardous medical product.(b)(6).Reference report: mw5148113.

Event Description

Additional information received from reporter for a report #mw5148114 on 12/29/2023.December 28th, 2023 access number: mw5148114 on october 16th, 2023 i filed the above referenced complaint.This is follow up.After returning the defective new resmed model 11 cpap machine w/resmed f20 mask to my dme provider ((b)(6)) i was issued another new machine but this time a resmed model airsense 10 w/ resmed f20 mask.I turned the machine on while still in the (b)(6) office and the fumes coming out smelled similar to the solvent smell that the model 11 emitted.I did not use the machine for therapy as a result but instead did another air quality test to see if this machine was emitting dangerous fumes.A solvent panel full scan (60 compounds) was performed and the results are attached.The resmed model 10 emits six times more methyl ethyl ketone than epa considers safe.So i am returning the resmed model 10 to my dme provider (b)(6).My old machine needs to be replaced but i cannot use the new machines because they are emitting toxic fumes known to cause harm to humans in concentrations- well over epa safety standards.The air quality tests i have been performing on these medical devices is something the epa and medwatch should be overseeing.The general public should not be relied on to police faulty manufacturing of cpap machines.From what i have witnessed from the testing of these two different model cpap machines and my becoming sick after using one of them-it is my opinion that every new machine should be air quality tested by a third party lab before it is issued to an apnea patient.The cost is approximately (b)(6) for the testing.The manufacturers are clearly not concerned for public safety and will continue to produce and sell defective cpap machines until regulatory authorities enforce quality control measures.Tested 6 times over epa acceptable levels at 12.I do not see in this report where i can attach the reports.Thank you, (b)(6).

• Brand Name: RES MED AIRSENSE 10 AUTOSET CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD.
• MDR Report Key: 18139216
• MDR Text Key: 328357390
• Report Number: MW5148114
• 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,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

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
• Device Model Number: MODEL 10 AUTOSET
• Device Catalogue Number: 37160
• Device Lot Number: 1713650
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/02/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White