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

Model Number SC1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.The customer was educated by customer care on proper maintenance of handwashing while using the device.The device does not replace proper cleaning and maintenance of the pap device according to the manufacturer's instructions.They did not want to hand wash their pap equipment and wanted to return their device.The customer experienced congestion in their chest and head resulting in a doctor's visit with prescribed medication.They discontinued use of the device and their symptoms persisted.Their symptoms are likely due to dirty pap equipment and does not relate to our device.Soclean has reviewed and made improvements to the complaint handling procedure to ensure compliance with fda regulations.These improvements were recommended because of an internal audit conducted by an external independent regulatory consultant.Soclean opened several capas to remediate the audit findings.Processes were revised to ensure reportable events were correctly identified and submitted to fda.Per fdas guidance, soclean is now reporting these events, which also includes retrospective items.

Event Description

Customer reports bad congestion in chest and head, cold symptoms.Md prescribed unspecified medication.Customer does not perform regular maintenance cleaning of the cpap equipment as stated in our ifu.

• Brand Name: SOCLEAN 2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, 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: 14165836
• MDR Text Key: 289731316
• Report Number: 3009534409-2022-00533
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/22/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 04/21/2022
• 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: Male