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

Device Problem Unexpected Shutdown (4019)

Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Unspecified Infection (1930); Nausea (1970); Cough (4457); Unspecified Eye / Vision Problem (4471)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Had significant symptoms chest pain, shortness of breath, cough, headache, nausea, sinus infection, runny nose, phlegm in back of throat, eyes irritated, neck and shoulder achy.Contacted doctors at (b)(6), who ordered multiple tests as i had previous serious medical conditions.The cardiac and chest x ray were negative.I contacted apri health care about my so clean machine to get new filters and to regulate my cpap machine which was turning off by itself.They had me reset the cpap machine and sent the new soclean filters, mask, tubing and cpap filters.As a result, i felt better and continued to use so clean and cpap machines, although increased my cleaning of mask etc.With soap and water again.I still have some chest pressure, running nose, shoulder and neck achiness, and will see my pulmonary specialist this thursday.My primary told me to talk with her about more testing.Then i just happened to see a news report yesterday about recalling the cpap machines and the so clean machine contribution to the problem.No one contacted me about this problem and i clearly have the symptoms.I will follow up with my pulmonary specialist, let me other doctors know, let the involved companies know (apria, medicare and phillips) and stopped using the machines.Fda safety report id (b)(\4).

• Brand Name: SOCLEAN MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12253527
• MDR Text Key: 264531867
• Report Number: MW5102873
• Device Sequence Number: 2
• Product Code: LRJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 101