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

Model Number	0210
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing becomes disconnected from the ventilator.
Additional Manufacturer Narrative
The nebulizer's failure to release aerosol and the tubing popping off would delay treatment to the patient.
Additional Manufacturer Narrative
The nebulizer's failure to release aerosol and the tubing popping off would delay treatment to the patient.Complaint is not confirmed.Testing of a different lot from inventory was found and units failed so ncmr-03535 was initiated.Reviewed the dhr and no quality issues were identified.Performed a risk analysis with rma-20013f and determined a severity rating of 6/10.Sent a resolution to the customer.
Event or Problem Description
Tubing becomes disconnected from the ventilator.

• Brand Name: WESTMED LLC
• Common Device Name: VIXONE 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: 17312277
• Report Number: 2028807-2023-00020
• Device Sequence Number: 6638804
• Product Code: CAF
• UDI-Device Identifier: 00709078000409
• UDI-Public: 00709078000409
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 412159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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