MAUDE Adverse Event Report: SOCLEAN, INC. VENTILATOR, NON-CONTINUOUS (RESPIRATOR); DISINFECTANT, MEDICAL DEVICES

Device Problem Nonstandard Device (1420)

Patient Problems Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/07/2021

Event Type  Injury  

Event Description

12-15-2021 this report reject by (b)(6) for further clarification from mgmt.Ema.Mild temperature and upper respiratory congestion and cough lasting over a week.This is the third upper respiratory issue that i've had in the last six plus months which i rarely have had in the past.I feel sure this is connected to the philips cpap dream machine which i was alerted about in (b)(6) 2021.I have registered my machine with philips and it is on the recall list.I was also using the soclean ozone cleaning device for my cpap which they said could exacerbate the problem of foam degradation.I did not find any black particles in my device or tubing but they said vocs could also be an unseen problem inhaled.My recent congestion/temp responded after multiple diagnosis tests to an antibiotic for the abatement of infection and temperature in the lungs, but i still have lingering upper chest congestion.I have decided not to use the cpap for the past two nights and do feel some improvement.I'm concerned that the replacement/repair by philips is proceeding so slowly as they don't anticipate resolution until sept.2022.I don't know how they are prioritizing replacements but this is entirely too long.They said back in june they were awaiting fda approval.Chest x-rays were normal and of no concern.Also had strep test that was negative.Fda safety report id# (b)(4).

• Brand Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13002560
• MDR Text Key: 282338329
• Report Number: MW5106032
• Device Sequence Number: 2
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 12/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: B COMPLEX; BETA GLUCAN; D-3; ECHINACIA; HYDROCHLOROTHIAZIDE 25MG; SAW PALMETTO; SELENIUM; TURMERIC; VITAMIN C; ZINC
• Patient Outcome(s): Disability; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White