MAUDE Adverse Event Report: ACCUTRON, INC. FLOWMETER, CM

Model Number	31970
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete and thorough test and evaluation was conducted of this.Could not duplicate reported problem of too much n2o flow.Unit meets factory specifications.
Event or Problem Description
Dr.Believes sedation levels are higher than unit shows.This unit was previously repaired and returned but dr.Complained that unit is making patients sick.

• Brand Name: FLOWMETER, CM
• 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: 22882511
• Report Number: 2020813-2025-00008
• Device Sequence Number: 8861136
• Product Code: BSZ
• UDI-Device Identifier: 00813830021141
• UDI-Public: (01)00813830021141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970163
• 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): 08/25/2025

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: 31970
• Device Catalogue Number: 31970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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