MAUDE Adverse Event Report: 3B MEDICAL INC. LUMIN CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Model Number LM3000

Device Problem Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Used lumin cpap mask cleaner, which uses uv light to sanitize silicone nasal cushion from factory sealed dreamwear nasal cushion, observed significant odor when opened lumin chamber.Previously read the odor was caused by it breaking down contaminates.There should not have been any contaminates on factory sealed cushion.Concerned using uv cleaner on nasal cushion may cause vocs.Fda safety report ids# (b)(4).

• Brand Name: LUMIN CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): 3B MEDICAL INC.
• MDR Report Key: 12894194
• MDR Text Key: 281531490
• Report Number: MW5105668
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 1778302040
• UDI-Public: 1778302040
• 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: 11/24/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: LM3000
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White