MAUDE Adverse Event Report: SOCLEAN,INC. SOCLEAN2; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN2

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Chest Tightness/Pressure (2463)

Event Date 08/31/2020

Event Type  Injury  

Event Description

I have been using a soclean machine to clean my cpap machine.I have used the machine for a little over 6 months.Last month was the first time that i started to have problems using my cpap machine.My nose and chest felt congested.My chest tightened up and felt restricted.I felt like i was suffocating with my cpap machine.I have used it for 3 years with no problem.Nothing had changed on my cpap machine except for the use of the soclean.After replacing all of the hoses and mask, i was able to sleep without feeling like i was suffocating.The ozone is staying in the hoses and was entering into my lungs, making it hard for me to breathe.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN,INC.
• MDR Report Key: 10843545
• MDR Text Key: 216881770
• Report Number: MW5097883
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN2
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 127