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	Unspecified Respiratory Problem (4464)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Blue piece of nebulizer falls off when package is opened.Treatment delayed up to 15 minutes.
Additional Manufacturer Narrative
The blue piece of nebulizer falls off when package is opened delayed patient treatment by 15 minutes.
Event or Problem Description
Blue piece of nebulizer falls off when package is opened.Treatment delayed up to 15 minutes.
Additional Manufacturer Narrative
The blue piece of nebulizer falls off when package is opened delayed patient treatment by 15 minutes.The defect of blue jet falling out of nebulizer upon opening could not be confirmed.A stock investigation for dimensional and proper attachment of the nebulizer jet was performed and the defect could not be replication.(b)(6) has been reviewed.The reported defect most closely matches to r32 which has a severity of 6 and occurrence of 3.Airlife will continue to perform complaint trending and may perform additional actions at that time.
Additional Manufacturer Narrative
The blue piece of nebulizer falls off when package is opened delayed patient treatment by 15 minutes.The defect of blue jet falling out of nebulizer upon opening could not be confirmed.A stock investigation for dimensional and proper attachment of the nebulizer jet was performed and the defect could not be replication.Rma-20013f has been reviewed.The reported defect most closely matches to r32 which has a severity of 6 and occurrence of 3.Airlife will continue to perform complaint trending and may perform additional actions at that time.Udi related data quality updates only.
Event or Problem Description
Blue piece of nebulizer falls off when package is opened.Treatment delayed up to 15 minutes.

• 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: 17914134
• Report Number: 2028807-2023-00028
• Device Sequence Number: 6777451
• Product Code: CAF
• UDI-Device Identifier: 00709078000409
• UDI-Public: (01)00709078000409(10)432784
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• 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: 0210
• Device Catalogue Number: 0210
• Device Lot Number: 432784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/11/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/22/2023; 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