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

Model Number	27076
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete and thorough test and evaluation was conducted.Both the digital main module and the control module meet factory specifications.No repairs or recalibration necessary.
Event or Problem Description
Distributor reported that a patient passed out within minutes of using nitrous.An ambulance was called, and patient was sent to the hospital.According to hospital report patient was fine; had an anxiety attack.

• 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 peak rd; phoenix AZ 85027
• Manufacturer Contact: stephanie wasielewski ; 1625 w pinnacle peak rd; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 23485443
• Report Number: 2020813-2025-00009
• Device Sequence Number: 10494086
• 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
• Report Date (Section B): 11/06/2025

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
• Date Returned to Manufacturer: 10/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2018
• 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