MAUDE Adverse Event Report: WESTMED LLC WESTMED; VIXONE NEBULIZER

Model Number 0210

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as if it were to recur it would require medical intervention.

Event Description

Will not nebulize.

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 Description

Will not nebulize.

• Brand Name: WESTMED
• Type of Device: 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
• MDR Text Key: 307807925
• Report Number: 2028807-2022-00024
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10709078000406
• UDI-Public: 10709078000406
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other