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

Model Number	31975
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete and thorough test and evaluation was conducted on the device in as received condition.Testing found o2 & n2o mixed gas flows were within in factory tolerances.Device tested and meets factory requirements.
Event or Problem Description
User facility reported that 2 patients got sick at 40% flow and dr.Was concerned about meter flowing accurately.

• Brand Name: ULTRA PC% 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: stephanie wasielewski ; 1733 west parkside ln.; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 21332938
• Report Number: 2020813-2025-00001
• Device Sequence Number: 8604053
• Product Code: BSZ
• UDI-Device Identifier: 00813830021158
• UDI-Public: (01)00813830021158
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 31975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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