MAUDE Adverse Event Report: SOCLEAN CPAP CLEANING DEVICE; DISINFECTANT, MEDICAL DEVICES

Device Problems Material Discolored (1170); Leak/Splash (1354); Device Emits Odor (1425); Gas/Air Leak (2946)

Patient Problems Sneezing (2251); Sleep Dysfunction (2517)

Event Date 05/10/2020

Event Type  malfunction  

Event Description

Pose health problems; we have been having some health problems like sneezing, coughing, and not sleeping well more than usual over the last several months.We also had problems with our cpap equipment making noise and our masks deteriorating, leaking and turning brown looking dirty.At first, we were blaming the machine which is a resmed air sense 10.It was until we checked on the internet to see if others were having the same problem with the machine and accessories.The equipment is the soclean and we did not know that they were not fda approved.They do a very good job of marketing this piece of equipment that i bought one for my wife on (b)(6) 2020.We will see our pulmonary doctor to check us and treat us.We will not use the soclean machine anymore and will attempt to seek a refund and will stop paying for the second machine.In addition, we now know that the smell we smelled when we cleaned the machine was the ozone gas escaping the soclean machine.The smell (ozone gas) was so strong that we would leave the room when the machine was supposedly cleaning the cpap equipment.I have enclosed some pictures of what the soclean machine would do to the mask after just one use.I can only imagine what it did to our lungs and throat.This machine should be illegal to sell especially since it does leak gas.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN CPAP CLEANING DEVICE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 10396341
• MDR Text Key: 202783048
• Report Number: MW5096029
• 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: 08/09/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Other
• Patient Age: 66 YR
• Patient Weight: 77