MAUDE Adverse Event Report: ACCUTRON, INC. NEWPORT FLOWMETER SYSTEM

Model Number 50000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

The user facility indicated the issue was intermittent and they do not have an exact number of patients impacted.Accutron was first made of aware of this issue on november 10, 2022.The unit subject of the event was returned to accutron for evaluation.The gas flows were tested and confirmed to be operating properly.During the evaluation it was found that the on/off valve required replacement.This caused an oxygen leak when the valve was in the off position.The issue with the valve would not have caused or contributed to the reported event.The newport flowmeter system user manual states (2), "warnings to be used only by a professional trained in the use of nitrous oxide.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o.If patient does not show signs of quick recovery, remove nasal mask and treat with pure oxygen from either the o2 resuscitator fitting or an auxiliary oxygen tank using a demand valve, oxygen assisted manual resuscitator, or equivalent.Call for emergency assistance if rapid response is not achieved." accutron made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.Accutron will offer in-service training on the proper use and operation of the newport flowmeter system.

Event Description

The user facility reported that during patient procedures involving the newport flowmeter patients became nauseous and some began to vomit.The patients were administered oxygen and fully recovered.No additional medical intervention was required.

Manufacturer Narrative

The user facility was offered in-service training on the proper use and operation of the newport flowmeter system; however, the user facility declined.No additional issues have been reported.

• Brand Name: NEWPORT FLOWMETER SYSTEM
• Type of Device: FLOWMETER
• Manufacturer (Section D): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15933120
• MDR Text Key: 307998729
• Report Number: 2020813-2022-00008
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830023305
• UDI-Public: 00813830023305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50000
• Device Catalogue Number: 50000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1