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

Device Problems Contamination /Decontamination Problem (2895); Device Damaged by Another Device (2915)

Patient Problem Cough (4457)

Event Date 07/10/2021

Event Type  malfunction  

Event Description

Cough and broke cpap; i have been using the soclean 2 automatic cpap cleaner for two years.Around (b)(6) 2021 i developed a persistent cough that i thought was allergies, and my resmed airsense 10 auto set cpap machine quit working shortly after.The motor became loud and the machine would not blow air.I would find bits of black pepper looking specs in my machine when i would wipe it down.I take allegra and use flonase daily but my cough persisted.I began researching and discovered the ozone cleaning method from the soclean unit was causing cpap machines to break down.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12452795
• MDR Text Key: 271075775
• Report Number: MW5103829
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 40 YR
• Patient Weight: 85