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

Model Number 0210

Device Problem Mechanical Problem (1384)

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

Event Date 09/25/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as this delayed patient treatment.

Event Description

Nebulizer failures (medication bubbles but not aerosol and tube popping off).

Event Description

Nebulizer failures (medication bubbles but not aerosol and tube popping off).

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
• Type of Device: 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
• MDR Text Key: 307622135
• Report Number: 2028807-2022-00022
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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: 080222N21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• 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