MAUDE Adverse Event Report: WESTMED LLC WESTMED; VIXONE NEBULIZER

Model Number	0210
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as if it were to recur it would require medical intervention.
Event or Problem Description
Will not nebulize.
Additional Manufacturer Narrative
Reportable as if it were to recur it would require medical intervention.The root cause cannot be definitely determined with the information given.Failure to nebulize could be from defective molding, or if the bottom of the nebulization cup is not screwed in all the way.Reviewed the dhrs and no causes for the reported defect were found.Reviewed the complaint history and there was no trending.Performed risk analysis and the severity rating of the complaint is 6/10.Sent resolution to the customer.
Event or Problem Description
Will not nebulize.

• Brand Name: WESTMED
• Common Device Name: VIXONE NEBULIZER
• Manufacturer (Section D): WESTMED LLC; 5580 s nagales hwy; 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: 15896826
• Report Number: 2028807-2022-00024
• Device Sequence Number: 12066889
• Product Code: CAF
• UDI-Device Identifier: 10709078000406
• UDI-Public: 10709078000406
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 112321N10, 040922N28, 112321N1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/26/2023
• 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