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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2 CPAP SANITIZING EQUIPMENT DISINFECTANT, MEDICAL DEVICES

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SOCLEAN, INC. SOCLEAN2 CPAP SANITIZING EQUIPMENT DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SOCLEAN2
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/16/2021
Event Type  Injury  
Event Description
I have been using a cpap machine since 2004. In (b)(6) 2017, i was issued a new resmed cpap machine which i use daily. On (b)(6) 2018 i started to disinfect my cpap machine daily with a unit called soclean2. I had it set to run in the am. I didn't experience any problems with this unit until (b)(6) 2021. When i woke up that morning ((b)(6) 2021), i experienced an awful smell in my nose, an awful taste on my tongue, and a very dry throat. I can only describe it like the smell of the ozone from the soclean2. The smell in my nose went away after about two days and the dry throat after one day. It took until (b)(6) 2021 for my tongue not to have the awful taste. Even when i ate food the taste would be there. I brushed my tongue with my tooth brush and still had the bad taste. My tongue had the feeling like there was a lot of salt on it. I had no breathing issues, no issue with my eyes, nor any other health issues. During the time from (b)(6) 2021, i did not resume using my cpap machine. Instead, i ran the cpap machine by itself for three days; several hours each day to try to flush out the ozone smell and i had no longer connected it to the soclean2 machine. Then on (b)(6) 2021, i resumed using my cpap machine again (without the use of the soclean2 machine) only to find on the morning of (b)(6) 2021 a problem with my tongue once again having the bad ozone taste. No throat, nose, breathing or eye issues. Just the bad taste on my tongue which i am still experiencing as i report this today, (b)(6) 2021. On (b)(6) 2021, i called soclean to report this issue. They went through a test with me over the phone to check on any issues with the machine or if i was doing something inadvertently wrong with it. They asked me to add water to the cpap reservoir chamber to see if bubbles occurred when running the soclean2 unit through the cpap machine. The water did bubble so this confirmed that i had everything hooked up correctly. They had me check the filter in the soclean2 unit to make sure the wrapping was removed, and it was. I asked them if they had changed the manufacturer for their filters and they responded no. They then recommended that i always have water in the reservoir chamber when running the soclean unit. I told them this was the first hearing about this procedure and that this information was not in their written instructions when i got the unit in 2018. They asked me to check on the level of ozone the machine was set on. I told them i never heard of that nor was that in their manual. They walked me through on how to do it and found that the level was set at a level 10 (which i told them was set from the factory unbeknown to me) and they said to lower it to a level 7 which i did. However, i was not planning to ever use this soclean2 machine again. I personally visited my cpap supplier on (b)(6) 2021 with my cpap machine and they decided to send my resmed cpap machine back to the manufacturer to see if they could get rid of the ozone smell in the unit at a cost to me. They never experienced a problem like this prior. I am now without a cpap machine until i hear back and this is not a healthy situation with sleep apnea. It was shipped to resmed on 02/26/21. When i asked soclean if this ozone problem would create any health issues for me they suggested that i see my doctor since they didn't have the medical experience on this matter. I saw my regular md today ((b)(6) 2021) and was checked out and didn't find any health issues. My doctor didn't have any prior experience with this problem but checked the fda and cdc website for detailed info pertaining to this issue and shared that with me. I am to check back with my doctor after one week if i am still experiencing the bad taste on my tongue. I have a date of (b)(6) 2021 for a follow-up if necessary. I would highly not recommend anyone use the soclean machine. I plan on using a manual washing protocol for may cpap supplies as recommended by my cpap supplier. Please feel free to call or email me about this issue. Fda safety report id # (b)(4).
 
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Brand NameSOCLEAN2 CPAP SANITIZING EQUIPMENT
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key11404288
MDR Text Key234934346
Report NumberMW5099745
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSOCLEAN2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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