MAUDE Adverse Event Report: RESPIFY CLEANER AND SANITIZER; DISINFECTANT, MEDICAL DEVICES

Model Number RES2019

Patient Problems Headache (1880); Discomfort (2330); Cough (4457)

Event Date 03/25/2024

Event Type  Injury  

Event Description

Just bought and used the respify cleaner.Followed instructions exactly, did the cleaning in the morning and then hoped it would air out by 10 pm.The smell of ozone lingered through the day.The next morning, today, after using the cpap all night, i awoke with a headache and lungs feeling tight.I also awoke during the night with a cough for a couple minutes.How is it best to air out all the ozone? i thought it would have been ok.

• Brand Name: RESPIFY CLEANER AND SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 18994249
• MDR Text Key: 338943772
• Report Number: MW5153326
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RES2019
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 10 MG; FLUTICASONE PROPIONATE SPRAY 50 MCG. ALL TAKEN ONCE PER DAY; LOSARTAN 100 MG; MELOXICAM 7.5 MG; OXYBUTIN CL ER 10 MG; TAMSULOSIN HCI 0.4 MG
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White