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

Model Number	0210
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as this delayed patient treatment.
Event or Problem Description
Nebulizer failures (medication bubbles but not aerosol and tube popping off).
Event or Problem Description
Nebulizer failures (medication bubbles but not aerosol and tube popping off).
Additional Manufacturer Narrative
Reportable as this delayed patient treatment.Complaint not confirmed due to lack of a photo or return.Reviewed the dhr and no anomalies were found.Received samples and all nebulized as expected.One of the samples had an unrelated fault that instigated ncmr-02911.Reviewed the complaint history and there was only one previous complaint for this part.There is no trending.Performed risk analysis with rma-20013b and the related risk is 6/10, less than the capa initiation threshold of 8.Sent a resolution to the customer.

• Brand Name: WESTMED LLC
• Common Device Name: VIXONE NEBULIZER
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales hwy; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 nogales hwy; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 15829743
• Report Number: 2028807-2022-00022
• Device Sequence Number: 5391619
• Product Code: CAF
• UDI-Device Identifier: 10709078000406
• UDI-Public: 10709078000406
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/18/2022

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: 0210
• Device Lot Number: 080222N21
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 01/05/2023
• 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