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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIRTUOX, INC. VIRTUCLEAN 2.0; DISINFECTANT, MEDICAL DEVICES
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VIRTUOX, INC. VIRTUCLEAN 2.0; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Patient Problems Discomfort (2330); No Code Available (3191)
Event Date 07/13/2020
Event Type  Injury  
Event Description
In (b)(6), i bought a virtu-clean cpap cleaner that uses ozone to clean my cpap device.I have used it daily since then.I have it set up in the garage, a room that is only occasionally visited and mostly not when the device is running.I ordinarily clean it many hours before i use the cpap device and run the cpap device for several minutes before i start using it.Still, the ozone odor is noticeable when i first put the cpap device on at night.For the past two weeks, i have been experiencing a slight, nonproductive but persistent cough that comes and goes throughout the day.(it does not seem to bother me during sleep when i am wearing the cpap mask.) i have no fever or other symptoms but it is concerning enough that i had a covid19 test yesterday that proved negative.In looking for possible causes, i came upon an fda press release indicating that ozone cpap cleaners have been known to cause coughing and encouraging the reporting that i am doing here.This just ruled out covid19 as the cause of my cough.Fda safety report id# (b)(4).
 
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Brand Name
VIRTUCLEAN 2.0
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
VIRTUOX, INC.
MDR Report Key10325978
MDR Text Key200666288
Report NumberMW5095714
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 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age82 YR
Patient Weight88
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