MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Device Problems Particulates (1451); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Since my sleep apnea diagnosis some years ago, i have used a cpap machine, currently a resmed airsense 10.It's hard to clean (i have parkinson's disease), so i bought a soclean 2 sanitizing device a few years ago.Recently i noticed when filling the distilled water reservoir (which i do daily) that there were dark green particles of various sizes in the water.I'm not sure what they were, but for one thing it appeared that the end of the tubing that goes into the reservoir had started to disintegrate.I called soclean and they were no help at all.This seems dangerous to me, so i have disconnected the soclean device and am using a new reservoir.Fda needs to look at these devices carefully and give us some guidance.Thanks.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN 2 CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12814198
• MDR Text Key: 280936024
• Report Number: MW5105307
• 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: 11/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White