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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FREESPIRA, INC. ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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FREESPIRA, INC. ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Patient Problems Anxiety (2328); Cough (4457)
Event Type  Injury  
Event Description
Hello, i would like to report what i experienced when undergoing treatment with freespira, as i believe this company may be falsifying their data.Freespira provides a treatment program that they claim has a high success rate in treating people with clinical anxiety, panic disorder, and ptsd.They have a research study article published which can be seen at https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc9712796/#.My health insurance provider sent me a mailer offering this program free to qualifying patients, and after finding the above article, i decided that it looked legitimate so i decided to try it out.They send you a tablet with preloaded software on it, as well as a sensor and a cannula.Twice a day for 28 days, you have 20 minute sessions breathing into the cannula while it is connected to the sensor.An app on the table displays your co2 levels and respiration rate.Your goal is to keep your respiration rate within the target range (which changes each week of treatment), and to always try to have your co2 be at 40 mmhg.They also connect you with a counselor who gives you the initial orientation to the equipment and app, is available by email any time, and there is a check-in meeting every week to talk about how you are doing and answer any questions.For the first 2 weeks of the program everything seemed pretty normal.My co2 numbers were consistently in the 34-37 range.I tried to breathe differently as the app recommended and my counselor described, but no matter what i tried, i did not seem to be improving much.My counselor told me this was normal for the beginning of treatment, and that it seemed to always "click" for people in week 3.I have included a screenshot from february 14th in the am which shows a typical result for me.It had been like this for the full 2 weeks of treatment, i was doing slightly better during this session but not by a ton.So you can consider this image to be fairly normal for me for the previous 2 weeks.Well, 2 sessions into week 3, all of a sudden my numbers were nearly perfect.Which is exactly what my counselor told me would happen.Here is why i don't buy it.I was actually feeling a bit panicky at the time of this session, and i know i was taking breaths that were too deep.For the entire previous 2 weeks, the app had been telling me to take in less breath.This time, i was breathing more and all of a sudden my numbers are perfect? this made no sense.So i tried doing a few things like taking super deep breaths and coughing etc.I had done a fair amount of coughing during the previous 2 weeks of sessions as i have chronic sinus issues and post nasal drip, and trying to breathe through my nose only exacerbates the coughing.Previously, any time i coughed, there would be a noticeable dip in my co2 and then the number would go back up after i stopped.This time? nothing.Line didn't budge at all.I tried this several times with no change in the reading.I then went overboard with trying to breathe huge breaths, lots of coughing, etc.And finally got the big dip in the graph to happen.This was february 14th pm and i included a screenshot.I decided to give it one more try.Maybe somehow i'd had a fluke result.So next morning, same thing.Nearly perfect results, despite me trying to cough and throw it off.There is no way these results are real.This was february 15th am and i included a screenshot.I also included images of the id info on the tablet and sensor.I initially reported this to the irb listed in the research study.After investigating, they came back to me and told me they don't have any authority over freespira, and suggested i report it to the fda.While no physical harm was caused to me, i am reporting this because: freespira is making a lot of money from selling this treatment program to health insurance providers and individuals, and if their research study is based on a lie, that is a scam.The mental toll of being offered a promising looking treatment only to discover it was based on a lie is crushing.Thank you for looking into this.If they are indeed scamming, i hope you can stop them.Reference report: mw5153193.
 
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Brand Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
FREESPIRA, INC.
MDR Report Key18985650
MDR Text Key338795011
Report NumberMW5153192
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Patient Sequence Number1
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