MAUDE Adverse Event Report: SO CLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problem Decrease in Pressure (1490)

Patient Problems Dyspnea (1816); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2022

Event Type  Injury  

Event Description

Customer reports respiratory infection, congestion and breathing difficulties.Required emergency room visit on several occasions and was given steroid/cortisone injections.The customer declined to discuss any treatment by her md other than he told her to stop using the soclean.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Customer stated that she received her philips respironics dreamstation and soclean at about the same time.She indicated that she did not know what was causing her symptoms until she received the recall notice for her cpap machine that contained information about the problems that occur from using ozone.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.

• Brand Name: SOCLEAN 2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SO CLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer Contact: jessica wilson ; 1 vose farm road; peterborough,, NH 03458 ; 6033712570
• MDR Report Key: 15199944
• MDR Text Key: 297609867
• Report Number: 3009534409-2022-00556
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Device Catalogue Number: SC1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female