MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN; DISINFECTANT, MEDICAL DEVICES

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Unspecified Infection (1930); Pneumonia (2011); Cough (4457)

Event Date 04/01/2021

Event Type  Injury  

Event Description

I am not certain of the original date of sinus infection, cough, and pneumonia.It was the month of april.I use the philips dreamstation bipap machine.I began experiencing breathing difficulties, upper airway infections, cough.Obtained chest x-ray, antibiotics.Continued signs of cough and difficulty breathing.History of cancer and chest x-ray was not definitive.Necessitated ct scan showing atelectasis and opacities in both lungs.Treated with antibiotics.Also used the soclean device for cleaning the machine.Now understand this is a problem relating to degradation of the unit.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12583378
• MDR Text Key: 275274977
• Report Number: MW5104416
• Device Sequence Number: 2
• Product Code: LRJ
• 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: 10/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Weight: 86