MAUDE Adverse Event Report: NATURES PILLOWS, INC., AND TOP DOG DIRECT, LLC CLEAN ZONE CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Model Number S4 PLUS

Device Problem Device Emits Odor (1425)

Patient Problems Irritation (1941); Chest Tightness/Pressure (2463)

Event Date 06/24/2020

Event Type  Injury  

Event Description

I purchased a clean zone cpap cleaner and began using it on june 24.It was several hours after the first cleaning that i first used the cpap after cleaning.It still smelled of ozone.I guessed this was normal and slept with it even though it was irritating.After three nights of cleaning the machine in the morning and using it at night, i developed a dry cough and my chest was tight.Today i started to research ozone effects on people and discovered that my symptoms were exactly as described.I have since cleaned the mask hose and water chamber with soap and water.There is still a residual odor.I guess i should change the filter as well.I discovered that the fda has not approved ozone for cleaning cpaps.How can these devices be on the market when they are not regulated? fda safety report id# (b)(4).

• Brand Name: CLEAN ZONE CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC., AND TOP DOG DIRECT, LLC
• MDR Report Key: 10217644
• MDR Text Key: 197319040
• Report Number: MW5095301
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: S4 PLUS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 104