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

Model Number	50000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2020813-2022-00008
• Device Sequence Number: 4347243
• Product Code: BSZ
• UDI-Device Identifier: 00813830023305
• UDI-Public: 00813830023305
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 50000
• Device Catalogue Number: 50000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown