FDA Adverse Event Injury Summary report: N

SLEEP8 CPAP'S SANITIZING COMPANION

MDR report key: 9524312 · Received December 26, 2019

Report

Report Number
MW5091899
Event Type
Injury
Date Received
December 26, 2019
Date of Event
December 8, 2019
Report Date
December 19, 2019
Manufacturer
SLEEP8, INC.
Product Code
LRJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1316689 SLEEP8 CPAP'S SANITIZING COMPANION DISINFECTANT, MEDICAL DEVICE LRJ SLEEP8, INC. SLP82043I ITEM#SLEEP_8-60224002606

Patients

Seq Age Sex Outcome Treatment
1 67 YR