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

Model Number SC-1200

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

Using the soclean cpap cleaning device caused the rubber tubing that is part of my mask headgear to turn a yellowish brown.I spoke to resmed and was told these cleaning devices can damage the cpap machine and related accessories.I will stop using the soclean but after reading your information, i wanted to report this issue as you recommended.I have asked the manufacturer for a refund.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2 CPAP SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 11421884
• MDR Text Key: 238403972
• Report Number: MW5099806
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 98