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

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/09/2021 Patient Sequence Number: 1