MAUDE Adverse Event Report: HEALTHCARE LOGISTICS SYSTEMS VIRTUCLEAN OZONE BASED CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Model Number XD1001731058

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 03/23/2020

Event Type  Injury  

Event Description

I have been coughing fairly consistently following the use of an ozone cleaner for my cpap about 4 months now.Well before covid-19.Feel fine most of day, cough in the morning - throat clearing type of cough and then late in the evenings.I did not know ozone cpap cleaners were not fda approved.This should be advertised.Fda safety report id# (b)(4).

• Brand Name: VIRTUCLEAN OZONE BASED CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): HEALTHCARE LOGISTICS SYSTEMS
• MDR Report Key: 9877293
• MDR Text Key: 185005899
• Report Number: MW5093905
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XD1001731058
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 118