[105557161]
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.
Patient Sequence No: 1, Text Type: D, B5