MAUDE Adverse Event Report: RESPONSIVE RESPIRATORY INC. PURIFY O3 PORTABLE CPAP CLEANER & SANITIZE; DISINFECTANT, MEDICAL DEVICES

Model Number 190-6000

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 03/01/2020

Event Type  Injury  

Event Description

In late (b)(6) of 2020, i purchased a purify o3 portable cpap cleaner & sanitizer on line.It is small, easy to use and take on trips, and the price was reasonable.For the most part, i have been pleased with the product as i no longer suffer from sinus infections like i did when i first started using my cpap machine and equipment two years ago, and was cleaning all of it myself; however, by (b)(6), i was developing a deep, dry cough but thought it was probably the result of allergens in the air.The cough worsened but i was not sick (no other symptoms) so i started researching ozone cpap cleaners, wondering if that was causing me to cough.I found out that coughs can occur as a result of using ozone cleaners.As of two days ago, i quit using the cleaner and sanitizer and am back to washing the equipment myself.I am not absolutely certain the cpap cleaner is the cause of my cough, but it developed not long after using the cleaner and the cough persists and it is now (b)(6).Below the bar code on the box my sanitizer came in states, "fda registered." fda safety report id# (b)(4).

• Brand Name: PURIFY O3 PORTABLE CPAP CLEANER & SANITIZE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): RESPONSIVE RESPIRATORY INC.
• MDR Report Key: 10332102
• MDR Text Key: 200805989
• Report Number: MW5095743
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/25/2022
• Device Model Number: 190-6000
• 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): Disability
• Patient Age: 74 YR
• Patient Weight: 93