MAUDE Adverse Event Report: PHILIPS/RESPIRONICS SOCLEAN CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Device Problem Nonstandard Device (1420)

Patient Problems Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

"yikes!" just read, so clean cpap cleaner is dangerous.I use my cpap every night for 8-9 hours for last 7 years.Used the so clean for five years.What do i need to do to see if i have health issue---right now, my sinuses seem to stay swollen and i don't breathe well out of my nose - stopped up but several inches into nose passage.Philips says ozone cleaning not work now (recall/studies ongoing).So clean says it works just fine.I don't know who to believe or what to do - i am a little scared here.Thank you for your help.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): PHILIPS/RESPIRONICS
• MDR Report Key: 14257496
• MDR Text Key: 290560678
• Report Number: MW5109458
• 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: 04/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ALOPURINOL; B1; B12; B6; DICLOVENAC; LIGHT HIGH BLOOD PRESSURE MED; PROZAC; WELBUTRIN
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White