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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2020

Event Type  malfunction  

Event Description

I was using soclean 2 for my cpap and started to notice charcoal like residue in my water chamber.I asked my cpap supplier about it and they asked if i used any cleaning device and told them i was using soclean 2.They instructed me to stop.I have a resmed machine and they told me that resmed will not honor warranty on any equipment that was purchased as of 2-20 and cleaned with soclean.I have had my machine for a couple of years so will be covered if need be but they advised me to stop using the soclean 2 which i did immediately.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: 9971720
• MDR Text Key: 188393026
• Report Number: MW5094171
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 93