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	Dizziness (2194)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that 3 patients got sick - instantly, during and end of procedures.One patient fainted.No emergency services were called and no patients vomited.
Additional Manufacturer Narrative
Testing was conducted on the suspected device.At no time was n2o gas present without the presence of o2 gas.Nitrous was accurate for whole range of 0-70%.Device meets factory specifications.

• Brand Name: FLOWMETER, CM
• Common Device Name: FLOWMETER
• Manufacturer (Section G): ACCUTRON INC.; 1733 west parkside ln.; pjhoenix AZ 85027
• Manufacturer Contact: stephanie wasielewski ; 1733 west parkside ln.; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 21901013
• Report Number: 2020813-2025-00002
• Device Sequence Number: 8794848
• 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): 04/24/2025

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: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown