MAUDE Adverse Event Report: WESTMED LLC VIXONE; SMALL VOLUME NEBULIZER

Model Number	0210
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When the nebulizer started, it did not nebulize medication.
Additional Manufacturer Narrative
When the nebulizer started, it did not nebulize medication, delaying patient treatment.
Additional Manufacturer Narrative
When the nebulizer started, it did not nebulize medication, delaying patient treatment.The defect of failure to nebulize could not be confirmed in the absence of a photo or sample.The risk associated with failure to nebulize was identified as 6-major which is below the threshold for immediate escalation.Airlife will continue to monitor complaints and trending.
Event or Problem Description
When the nebulizer started, it did not nebulize medication.
Additional Manufacturer Narrative
When the nebulizer started, it did not nebulize medication, delaying patient treatment.The defect of failure to nebulize could not be confirmed in the absence of a photo or sample.The risk associated with failure to nebulize was identified as 6-major which is below the threshold for immediate escalation.Airlife will continue to monitor complaints and trending.**udi related data quality updates only**.
Event or Problem Description
When the nebulizer started, it did not nebulize medication,.

• Brand Name: VIXONE
• Common Device Name: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18051735
• Report Number: 2028807-2023-00029
• Device Sequence Number: 8254366
• Product Code: CAF
• UDI-Device Identifier: 00709078000409
• UDI-Public: (01)00709078000409
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K800562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0210
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown