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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 PAP DISINFECTING DEVICE DISINFECTANT, MEDICAL DEVICES

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SOCLEAN, INC. SOCLEAN 2 PAP DISINFECTING DEVICE DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SC1200
Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Headache, Lumbar Puncture (2186); Palpitations (2467); Cough (4457)
Event Date 08/29/2020
Event Type  Injury  
Event Description
I have been using a cpap machine for about a year now. When i purchased my cpap machine i also purchased a so clean device. After using the so clean machine in the first month i noticed i started to develop a dry cough. I am in pretty good shape and i mountain bike usually 2 times a week. I started to notice on my bike rides or other strenuous activities where i was getting heart palpitations, headaches, and shortness of breath. I didn't realize what was causing it at the time. I was starting to think i was just getting old. The symptoms started to get worse over time, and finally one night i thought maybe it has something to do with the so clean machine. I started to research how harmful breathing ozone can be on humans. I found that people were complaining about the same symptoms that i was having. I thought how could a company just sell a device that can cause harm to people. I followed the directions on how to use the machine in the user manual. They recommend waiting for the green light on the machine before using your cpap machine for use. I always replaced the filters when the machine told me it was time to. My wife and i could always smell the ozone whenever the machine was running but thought it was safe because the instruction manual says that it is a closed system. My wife started to also develop a dry cough anytime i used the machine. I stopped using the machine about two months ago and my symptoms have slightly dissipated, but i still feel short of breath, and sometimes feel heart palpitations. I am worried about my long term side effects, and how long it will take for some of the symptoms to completely go away. I have stopped using the machine completely and now i just use mild dish detergent to clean my equipment. I also found out that this machine will void the warranty of my cpap machine. None of this was disclosed through the vendor (aerocare). They say that this machine is fda registered on the box. I just thought that it meant it was approved as well. I feel i was misled and now may have some permanent damage to my lungs and possibly my wife's as well. Please feel free to reach out to me anytime. My number is (b)(6). Thank you for your time. (b)(6). Fda safety report id# (b)(4).
 
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Brand NameSOCLEAN 2 PAP DISINFECTING DEVICE
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10656027
MDR Text Key210630171
Report NumberMW5097149
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC1200
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

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
Treatment
FLONASE; RES MED CPAP MACHINE; VITAMIN D; ZICAM; ZYRTEC
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