MAUDE Adverse Event Report: SLEEP8, INC. SLEEP8 CPAP'S SANITIZING COMPANION ; DISINFECTANT, MEDICAL DEVICE

Model Number SLP82043I ITEM#SLEEP_8-60224002606

Device Problems Product Quality Problem (1506); Contamination /Decontamination Problem (2895)

Patient Problems Itching Sensation (1943); No Code Available (3191)

Event Date 12/08/2019

Event Type  Injury  

Event Description

I cleaned my cpap equipment after wearing it for 9 mins, i took it off, my chest and lungs felt funny.The smell and taste like chlorine and my hands and face felt itchy.I took a shower and read how this machine works.Activated oxygen known as ozone or o3.I read, using activated oxygen, the sleep8 cleans, sterilizes, and sanitizes the cpap equipment without the use of water.The ozone cleaning technique disinfects the equipment, eliminating the breeding ground for germs, mold or other contaminants, (b)(6) 2019.The cpap shop, blog - sleep8; sleep8 cpap sanitizer review - the cpap shop; when inhaled, ozone can damage the lungs.Relatively low amounts of ozone can cause chest pain, coughing, shortness of breath and lung irritation.Animal studies suggest that long term exposure to ozone may lead to permanent scarring of lung tissue, loss of lung function and reduced lung elasticity, (b)(6) 2016.Recently it has been reported that a chronic contact with o3 can be deleterious for the skin.Our group and others have shown a progressive depletion of antioxidant content in the stratum corneum and this can then lead to a cascade of effects resulting in an active cellular response in the deeper layers of the skin.Https://www.Ncbi.Nlm.Nih.Gov>pub.; whether in its pure form or mixed with other chemicals, ozone can be harmful to health.When inhaled, ozone can damage the lungs.Relatively low amounts of ozone can cause chest pain, coughing, shortness of breath and lung irritation, (b)(6) 2016.- (b)(6).; problems with ozone generators and ionizers that produce ozone, allergy.

• Brand Name: SLEEP8 CPAP'S SANITIZING COMPANION
• Type of Device: DISINFECTANT, MEDICAL DEVICE
• Manufacturer (Section D): SLEEP8, INC.
• MDR Report Key: 9524312
• MDR Text Key: 173232387
• Report Number: MW5091899
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SLP82043I ITEM#SLEEP_8-60224002606
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 84