MAUDE Adverse Event Report: MASTER FX, INC. ATMOSCLEAN; DISINFECTANT, MEDICAL DEVICES

Model Number ATMOSCLEAN VAPOR SANITIZING SYST

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Doesn't sanitize as expected; this company is claiming without evidence that their sanitizing liquid delivery system is effective.Only the liquid has been proven effective.The fogging system that converts the liquid to gaseous state which then condenses into tiny droplets in the air, has not been shown to be effective as claimed.(b)(6).Fda safety report id # (b)(4).

• Brand Name: ATMOSCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): MASTER FX, INC.; 1350 w washington st.; west chicago IL 60185
• MDR Report Key: 10312093
• MDR Text Key: 200214894
• Report Number: MW5095671
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATMOSCLEAN VAPOR SANITIZING SYST
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 91