MAUDE Adverse Event Report: VIRTUOX/HEALTHCARE LOGISTICS SYSTEMS VIRTUCLEAN; DISINFECTANT, MEDICAL DEVICES

Device Problems Device Emits Odor (1425); Product Quality Problem (1506)

Patient Problems Headache (1880); Respiratory Distress (2045)

Event Date 03/27/2018

Event Type  Injury  

Event Description

I am writing about a device sold through every dme and online, the virtuclean cpap cleaner made by virtuclean.My friend uses a cpap machine.She was complaining about a worsening cough.When i was in her home, i noticed i got an immediate very strong headache.I saw that she had a device running that had a strong odor.I started looking at it.Later i went home and researched.I started studying what was available online under the epa warnings on ozone.I (b)(6) and found fda regulations on medical devices that emit ozone (21 cfr 801.415).I then started looking at the warning labels on the virtuclean.There were none.I then read that max ozone allowed was 0.05 ppm.I have a friend who works with gases and he lent me an ozone meter.I measured the virtuclean running in my bathroom, following the labeled instructions and the room ozone level was 4.5 ppm, or almost 1,000 times the legal limit.That would explain my friend's breathing problems and my headache.The more i read the more angry i became.The fda rule requires the device to carry warnings.It does not.The fda rule requires that the device labeling list the ozone level emitted.It does not.I think this device is dangerous and unsafe because it contains no warnings on use.The ozone emitted is so high it should be used outdoors only.The label advises that a pt can use their cpap after 20 minutes.It took 2.5 hours for the air in my bathroom to drop to the legal limit.

• Brand Name: VIRTUCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): VIRTUOX/HEALTHCARE LOGISTICS SYSTEMS
• MDR Report Key: 7432870
• MDR Text Key: 105557161
• Report Number: MW5076505
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other