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

Device Problem Nonstandard Device (1420)

Patient Problems Atrial Fibrillation (1729); Headache (1880); Dizziness (2194); Cough (4457)

Event Date 01/01/2021

Event Type  Injury  

Event Description

I put (b)(6) of 2021 as a reference point.I started having dizziness/headaches/fluctuating blood pressure, issues with coughing and have had a slightly elevated co2 in my blood for over 3 years.I was talking with my doctor about these symptoms and trying to figure out what was going on when i received the respironics cpap recall.I used a dream station for 5 years and also used the soclean to clean the machine with the mfg.Attachment.Receiving the recall notice was extremely upsetting for me and in the process of switching machines to one that was not defective, i suffered an afib episode and was hospitalized.All respironics and the fda are talking about is how to "switch out" a defective machine for one that is not defective however; no one is telling me how to determine if the machine i used for 5 years is actually defective and may have actually harmed my health.What is the fda doing about helping individuals find out if the recalled cpap machine they were using was in fact defective and may have harmed their health? what tests should be done on the machine and the individual to determine that no harm has come to them? did the off gasses from the recalled cpap damage my lungs, kidneys, etc., and/or, in the future, will my health suffer? the fear of the unknown is in itself affecting my health.Please provide me with information to determine if the recalled cpap machine i used for 5 years was defective and if so, how it may have affected my health given the symptoms i have been experiencing for sometime now.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12547177
• MDR Text Key: 274340984
• Report Number: MW5104262
• Device Sequence Number: 2
• 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: 09/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 56 YR
• Patient Weight: 122