MAUDE Adverse Event Report: WESTMED LLC VIXONE; VIXONETM NEBULIZER WITH SUPER SPIKE PEDIATRIC MASK AND THREADED NUT

Model Number	0313
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customers saying the nebulizer isn't aerosolizing. .
Additional Manufacturer Narrative
The nebulizer isn't aerosolizing delayed patient treatment.
Event or Problem Description
Customers saying the nebulizer isn't aerosolizing. .
Additional Manufacturer Narrative
The nebulizer isn't aerosolizing delayed patient treatment.The defect of failure to nebulize was unable to be confirmed in the absence of a returned sample.Rma-20013f revision 1 has been reviewed.This type of failure has been included and assessed for risk on lines r19-r24, r27, r28, r33, r40, r58, r59, r62-r64, and r81-r84.The highest severity associated with the line items is 6 - major and with an occurrence of up to 4.Airlife will continue to monitor trending of the complaint and may perform additional actions at that time.
Event or Problem Description
Customers saying the nebulizer isn't aerosolizing.
Additional Manufacturer Narrative
The nebulizer isn't aerosolizing delayed patient treatment.The defect of failure to nebulize was unable to be confirmed in the absence of a returned sample.Rma-20013f revision 1 has been reviewed.This type of failure has been included and assessed for risk on lines r19-r24, r27, r28, r33, r40, r58, r59, r62-r64, and r81-r84.The highest severity associated with the line items is 6 - major and with an occurrence of up to 4.Airlife will continue to monitor trending of the complaint and may perform additional actions at that time.Udi related data quality updates only.

• Brand Name: VIXONE
• Common Device Name: VIXONETM NEBULIZER WITH SUPER SPIKE PEDIATRIC MASK AND THREADED NUT
• 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: 18068625
• Report Number: 2028807-2023-00031
• Device Sequence Number: 12704962
• Product Code: CAF
• UDI-Device Identifier: 00709078000607
• UDI-Public: (01)00709078000607
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0313
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 10/05/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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