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

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).

• Brand Name: SOCLEAN 2 PAP DISINFECTING DEVICE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10656027
• MDR Text Key: 210630171
• Report Number: MW5097149
• Device Sequence Number: 1
• Product Code: LRJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLONASE; RES MED CPAP MACHINE; VITAMIN D; ZICAM; ZYRTEC
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 84