MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-25 for C-PAP MACHINES manufactured by Resmed Corp.
[2734676]
Add'l info rec'd from rptr (b)(6) 2012: i am continuing my efforts to secure a fitted mouthpiece which shifts my jaw very slightly forward to provide a little more air to go into my lungs. I have now been measured for the mouthpiece and it is supposed to be ready in about 2 weeks to be put in and tested. This is used only at night while sleeping. The beauty is that there are no machine air issues or masks to deal with. To date, (b)(6), the people who sold me the c-pap equipment in (b)(6), continue to be interested in my progress with the fda and resmed and my fitted mouthpiece because they are concerned about their customers. So far to date, my doctor who did the testing in his lab and recommended the product, has still failed to respond. I thought i would send you the updated communications i have had with resmed to keep you up to speed. I think you will find the correspondences very interesting. Following my last response to their request for specific product info and mailing the product itself that i have been using, there has been no further response. I didn't feel it was necessary to mail them my equipment since i gave them all the specific info, as well as their own reference describing the product deficiency. Interestingly enough, it appears that resmed is starting to offer a product along the lines in what i am working toward for an appliance that fits over your teeth.
Patient Sequence No: 1, Text Type: D, B5
[2823602]
Virtual suffocation when i tried to use the mesh version over my nose. Leakage of air when i shift my sleeping/breathing position which can wake me up and also after 40 seconds turns off the air from the machine and hopefully moves the little tab so you can still breathe. The description of this by the people who sold it to us and my doctor was not described in detail, so when the machine turned off, i thought it was a failure. When this happened twice in two hours while i was on a cruise ship, i stopped using it because i thought it was a product failure. Should the tab not move properly to allow breathing in the mask, the user might suffocate with no warning. I have an add'l solution to protect the c-pap user which is superior to the current product. When the user turns on the machine after connecting the hose to the mask, it sets an indicator that the machine is on and functioning. Should the machine turn off for the reasons listed above, it will turn on an audible alarm to wake up the pt/alert them to the fact that there is a problem/the air has been turned off. The user can then safely remove the mask and turn off the system and either start over or deal with the failure. When i first was told about the product by my doctor and the people who sold me the machine, i warned them of the potential risk with the product and they didn't seem to be concerned. Maybe because i was the pt, not them. My doctor told me that his pts really liked the product. After the issues i encountered i found out that 50% of the people who used the product stopped using it. Perhaps a number did so because they were fearful of suffocating. Should the current product fail, users could be suffocated and there could be lawsuits against the company, as well as the sellers and doctors who prescribe it, by the survivors of the users. I would appreciate hearing back on this subject and hopefully my idea will be implemented. It should be easy to do. Here is my most detailed solution to your product to help and protect your users. When the c-pap machine is turned on it sets an electronic flag in the machine that it is on. Should the mask start leaking air, which is quite easy if the user changes their head position and it turns off the air to the mask within 40 seconds or there is a power failure which results in the same result, an appropriate message will be activated verbally (perhaps adjustable based on pt hearing ability), to alert the user to remove their mask immediately. One message would be: "there has been a leak in your mask which has caused the turn off of your air by the c-pap machine. Please remove your mask immediately to prevent loss of air to your nose, mouth, and lungs. " the other message would be: "there has been a power failure which has caused the turn off of your air by the c-pap machine. Please remove your mask immediately to prevent loss of air to your nose, mouth, and lungs. " when the user purchases your c-pap machine, the above should be explained to them, as well as showing them the little plastic piece that has to change position with a loss of air, or there could be a dangerous situation to the user. I have started looking into fitted mouthpieces over my teeth which are tailored to the size and shape of my mouth and teeth, which are used to slightly shift my tongue forward to provide a little more room for air to get into my throat and lungs. This can eliminate the risks and high costs of your product as it stands now. I was also wondering if there has been any research regarding the use of your product over time on the pts with all the air injected into their systems every night. Could there be any damage to organs and other body parts? From my own standpoint over a few months, i have experienced dry throat, hardened mucous in my nose, and some swelling issues, as well as pulling my hair out. My new doctor spent considerable time explaining how our bodies are completely formed by age 20 and after that there can be deterioration due to age and weight gain. Weight gain can cause an increase in size of many parts of our body that can contribute to sleep apnea. People who have had significant weight gain can get sleep apnea at a much earlier age. The aging process can also cause some increase in the size of body parts or loss of firmness related to sleep apnea, which again can affect the passage of air into our throat and lungs. The other item which can affect sleep apnea is our genetic background from the past. There is also a possibility of surgery to reduce the risk of sleep apnea, which has its own risks. If a doctor spent more time on this subject with each pt, they might better understand their situation and do what is best based on their specific situation. Since i haven't heard anything back, i will wait another week or two. If there has still been no response, i think it is time to contact the food and drug administration and see what they think. This would include sending them copies of what i have sent to you and responses to date. I have been on their web-site and have all the contact info. The ball is now in your court again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025965 |
| MDR Report Key | 2634223 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-25 |
| Date Added to Maude | 2012-07-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-PAP MACHINES |
| Generic Name | C-PAP |
| Product Code | NHJ |
| Date Received | 2012-06-25 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP |
| Manufacturer Address | 9001 SPECTRUM CENTER BLVD SAN DIEGO CA 92123 US 92123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-25 |