MAUDE Adverse Event Report: UNKNOWN OZONE CLEANING MACHINE; DISINFECTANT, MEDICAL DEVICES

Patient Problems Aspiration/Inhalation (1725); Inflammation (1932); Sleep Dysfunction (2517); Unspecified Respiratory Problem (4464)

Event Date 09/12/2023

Event Type  Injury  

Event Description

Finally became aware of problem with the phillips cpap which i had been using since 2017.Developed lung problems and continue with lung inflammation.This has occurred since i stopped using the machine.I had also been using the ozone cleaning machine, which they say aggravated the problem.I use a new resmed airsense 11 but have had difficulty adjusting to the new machine.This has meant sleep loss and other health problems.Done at (b)(6).Reference report: #mw5149499.

• Brand Name: OZONE CLEANING MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18392319
• MDR Text Key: 331440402
• Report Number: MW5149500
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: B-2.; FOSAMAX.; MAGNESIUM.; NORTRIPTYLINE.; PROPRANOLOL.; PROSCAR.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White