MAUDE Adverse Event Report: ACCUTRON, INC. FLOWMETER, DIGITAL FLUSHMOUNT

Model Number	27076
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned for investigation.
Event or Problem Description
Distributor stated that (b)(6) reported that during procedure, the patient experienced dizziness and nausea.According to the operator, even when the nitrous oxide concentration was set to 0% (oxygen-only mode), the patient still appeared to be affected as if nitrous oxide was being delivered.
Additional Manufacturer Narrative
Device returned to manufacturer.Test and evaluation was conducted in as received condition and could not duplicate reported problem of high n2o flow.When o2 gas was not present, n2o would not flow, proving failsafe system is working.Device meets factory specification.Likewise, the dhr review did not identify any issues with the unit that may have contributed to the reported failure mode.

• Brand Name: FLOWMETER, DIGITAL FLUSHMOUNT
• Common Device Name: FLOWMETER
• Manufacturer (Section D): ACCUTRON, INC.; 1625 w. pinnacle peak rd.; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1625 w. pinnacle rd.; phoenix AZ 85027
• Manufacturer Contact: stephanie wasielewski ; 1625 w. pinnacle peak rd.; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 24639176
• Report Number: 2020813-2026-00001
• Device Sequence Number: 21281248
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: (01)00813830020885
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 27076
• Device Catalogue Number: 27076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown