MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA PC% CABINET MOUNT FLOWMETER

Model Number	27514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure involving the ultra pc% flowmeter the patient went blue and started seizing.The patient was sent to the emergency room and was reported to have fully recovered.
Additional Manufacturer Narrative
Accutron has contacted the user facility requesting the device subject of the event be returned to accutron for evaluation.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The user facility indicated the reported event occurred on july 14, 2022 and accutron was first made aware of this issue on october 7, 2022.The user facility has continued to use the unit subject of the event since july 2022 and no additional issues have been reported.Through follow-up with the user facility, accutron learned that immediately following the reported event user facility personnel had administered 100% oxygen for 10 minutes and the patient recovered.As a precaution, the patient was sent to the emergency room for evaluation.Accutron requested and received the unit subject of the event for evaluation.The unit was tested and found to be operating according to specifications.The ultra pc% cabinet mount flowmeter instructions for use states, "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.".Accutron counseled user facility personnel on the proper use and operation of the flowmeter.No additional issues have been reported.

• Brand Name: ULTRA PC% CABINET MOUNT FLOWMETER
• 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: 15735581
• Report Number: 2020813-2022-00006
• Device Sequence Number: 2983838
• Product Code: BSZ
• UDI-Device Identifier: 00813830023701
• UDI-Public: 00813830023701
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 27514
• Device Catalogue Number: 27514
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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