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

Model Number SC1200

Device Problems Decrease in Pressure (1490); Pressure Problem (3012); Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Customer reports skin irritation where pap mask comes in contact with face.Described as a red, burning sensation.Dermatologist seen.Received 1% triamcinolone cream.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Upon recurrence, the reported malfunctions, even in conjunction, would not be likely to cause or contribute to a death or serious injury, because of the following mitigating factors therefore, this is not reportable.The device failed for low air flow functionality.The failure relates to the unit's air pump.The air pump is required for the transport of ozone through the pap equipment, into the soclean 2 chamber, and through the carbon filter.The soclean 2 device is unable to transport the ozone without the air pump.As the device will transport less or no ozone in the case of low air flow.The device failed for pressure functionality.The failure relates to the unit's air pump.The air pump is required for the transportation of ozone through the pap equipment, into the soclean 2 chamber, and through the carbon filter.The soclean 2 device is unable to transport the ozone without the air pump.As the device will transport less or no ozone in the case of low pressure if there is impingement of the hose or pap equipment.The device failed for pressure drop.The failure relates to the units internal check valve, which is designed to protect the inner components of the soclean device to prevent water damage.In accordance with our ifu, the device shall be setup with the external check valve and replaced every 6 months.Therefore, this is not reportable.

• 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 ; 6033702571
• MDR Report Key: 17072428
• MDR Text Key: 316800444
• Report Number: 3009534409-2023-00032
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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: 06/05/2023
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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