MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

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

Patient Problem Pneumonia (2011)

Event Date 01/28/2022

Event Type  Injury  

Event Description

Customer reports he was on a cruise ship in 2020 quarantined due to covid , he developed pnuemonia and had to be evacuated off the ship and admitted to the hospital.He has seen several doctors since then for contunued unspecified respiratory problems, with no diagnosis, allergies and asthma were ruled out.He was prescribed inhalers in the past that did not help the ysmptoms.Currently using flonase, historically an allergy medicaition, that was prescriber back in oct.Of 2021.It has not brought a signifigant decrease in the symptoms.It is important to note that the customers cpap has been recalled and the customer did not follow our ifu on maintenance/hand washing.It is unclear if this injury is directly related to the soclean or the customers pre-existing exposure to covid.

Event Description

Customer reports he was on a cruise ship in 2020 quarantined due to covid , he developed pnuemonia and had to be evacuated off the ship and admitted to the hospital.He has seen several doctors since then for contunued unspecified respiratory problems, with no diagnosis, allergies and asthma were ruled out.He was prescribed inhalers in the past that did not help the ysmptoms.Currently using flonase, historically an allergy medicaition, that was prescriber back in (b)(6) 2021.It has not brought a signifigant decrease in the symptoms.It is important to note that the customers cpap has been recalled and the customer did not follow our ifu on maintenance/hand washing.It is unclear if this injury is directly related to the soclean or the customers pre-existing exposure to covid.

• Brand Name: SOCLEAN 2
• Type of Device: D2 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 willson ; 1 vose farm road; peterborough, NH 03458 ; 6033712570
• MDR Report Key: 13526346
• MDR Text Key: 285570638
• Report Number: 3009534409-2022-00501
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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: 02/08/2022
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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): Hospitalization
• Patient Sex: Male