MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN 2; DISINFECTANT, MEDICAL DEVICES

Device Problems No Fail-Safe Mechanism (2990); Misassembly by Users (3133)

Patient Problem Aspiration/Inhalation (1725)

Event Date 01/07/2022

Event Type  Injury  

Event Description

My (b)(6) year-old father was just recently discharged from the hospital after copd exasperation.And staying at my parents house to organize medical care, i attempted to assist my dad with using his cpap which has been prescribed to him for many years.Unfortunately, he is experiencing dementia associated with his parkinson's and has difficulty remembering how do use many of his medical equipment items.He had a soclean2 machine next to his cpap that he used to sanitize every day.He has had this machine for at least two years but we're not sure of the purchase date.In my attempt to assist my dad in using his cpap and sanitizing machine i noticed there was a tube connected to the back that was just dangling behind his nightstand.Internet research on the equipment confirm that this tube was supposed to be connected to an adapter on his cpap machine so that the ozone from the soclean 2 machine would go through the tube into the cpap humidifier container as part of the entire cleaning system.So essentially ozone was leaking out of the cleaning machine and into my dad's bedroom for at least the last two years.His respiratory condition has progressed without any known reason.My concern is that the reason is because of this cleaning system not including the adapter and it's purchased for his cpap machine.Apparently this must be purchased separately.At a minimum there should be a safety feature that doesn't allow the machine to work if the tube is not connected to something.Perhaps some kind of shut off feature or something.This just makes no sense.My dad was not a heavy smoker so his copd is likely more related to being exposed to chemicals working for (b)(6).I'm grateful that my husband did the research to discover how to properly use this cleaning system that led us to figuring out the tube not being connected in the back for the ozone fumes.We did go online to purchase the adapter this evening and we will not use the cleaning system until the adapter arrives.Who knows what damage has occurred in the meantime due to exposure to ozone to both of my parents.As my mother also sleeps in the same room and hasn't smoked a day in her life.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13237236
• MDR Text Key: 283833188
• Report Number: MW5106602
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White