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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SLEEP8, INC. SLEEP8 CPAP'S SANITIZING COMPANION DISINFECTANT, MEDICAL DEVICE

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SLEEP8, INC. SLEEP8 CPAP'S SANITIZING COMPANION DISINFECTANT, MEDICAL DEVICE Back to Search Results
Model Number SLP82043I ITEM#SLEEP_8-60224002606
Device Problems Product Quality Problem (1506); Contamination /Decontamination Problem (2895)
Patient Problems Itching Sensation (1943); No Code Available (3191)
Event Date 12/08/2019
Event Type  Injury  
Event Description
I cleaned my cpap equipment after wearing it for 9 mins, i took it off, my chest and lungs felt funny. The smell and taste like chlorine and my hands and face felt itchy. I took a shower and read how this machine works. Activated oxygen known as ozone or o3. I read, using activated oxygen, the sleep8 cleans, sterilizes, and sanitizes the cpap equipment without the use of water. The ozone cleaning technique disinfects the equipment, eliminating the breeding ground for germs, mold or other contaminants, (b)(6) 2019. The cpap shop, blog - sleep8; sleep8 cpap sanitizer review - the cpap shop; when inhaled, ozone can damage the lungs. Relatively low amounts of ozone can cause chest pain, coughing, shortness of breath and lung irritation. Animal studies suggest that long term exposure to ozone may lead to permanent scarring of lung tissue, loss of lung function and reduced lung elasticity, (b)(6) 2016. Recently it has been reported that a chronic contact with o3 can be deleterious for the skin. Our group and others have shown a progressive depletion of antioxidant content in the stratum corneum and this can then lead to a cascade of effects resulting in an active cellular response in the deeper layers of the skin. Https://www. Ncbi. Nlm. Nih. Gov>pub. ; whether in its pure form or mixed with other chemicals, ozone can be harmful to health. When inhaled, ozone can damage the lungs. Relatively low amounts of ozone can cause chest pain, coughing, shortness of breath and lung irritation, (b)(6) 2016. - (b)(6). ; problems with ozone generators and ionizers that produce ozone, allergy.
 
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Brand NameSLEEP8 CPAP'S SANITIZING COMPANION
Type of DeviceDISINFECTANT, MEDICAL DEVICE
Manufacturer (Section D)
SLEEP8, INC.
MDR Report Key9524312
MDR Text Key173232387
Report NumberMW5091899
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberSLP82043I ITEM#SLEEP_8-60224002606
Was Device Available for Evaluation? No Answer Provided
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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