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

Model Number 0210

Device Problem Connection Problem (2900)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

The oxygen tubing has popped off the ventilator oxygen port several times when doing in line treatments on the circuits.

Manufacturer Narrative

The oxygen tubing on nebulizer popped off the ventilator oxygen port several times when doing in line treatments on the circuits.This would delay treatment for the patient.The criteria for reporting an adverse event have been met based on the reported information.

Manufacturer Narrative

The oxygen tubing on nebulizer popped off the ventilator oxygen port several times when doing in line treatments on the circuits.This would delay treatment for the patient.The criteria for reporting an adverse event have been met based on the reported information.The complaint of "oxygen tube disconnects from port during use" regarding part 210 was confirmed.The root cause was not determined but could possibly be a result of mating dimension incompatibility.A risk assessment was performed, and the ultimate risk was determined to be medium which would require reporting to the capa review board but ncmr - 03535 has been previously opened for this issue.There have been 4other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

Event Description

The oxygen tubing has popped off the ventilator oxygen port several times when doing in line treatments on the circuits.

• Brand Name: WESTMED LLC
• Type of Device: 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: 17637192
• MDR Text Key: 322110990
• Report Number: 2028807-2023-00025
• Device Sequence Number: 1
• Product Code: CAF
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: 401575, 429822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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