MAUDE Adverse Event Report: ACCUTRON, INC. DIGITAL ULTRA FLUSHMOUNT PACKAGE H; FLOWMETER AND SCAVANGING CIRCUIT

Model Number	56800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete and thorough test and evaluation was conducted of device in as received condition and could not duplicate reported problem.Device meets factory specifications.
Event or Problem Description
Distributor reported patients getting sick on n2o.Two patients vomited mid-treatment on different days in this same room.

• Brand Name: DIGITAL ULTRA FLUSHMOUNT PACKAGE H
• Common Device Name: FLOWMETER AND SCAVANGING CIRCUIT
• Manufacturer (Section D): ACCUTRON, INC.; 1625 w pinnacle peak rd; AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1625 w pinnacle peak rd; AZ 85027
• Manufacturer Contact: stephanie wasielewski ; 1625 w pinnacle peak rd; 8472574500
• MDR Report Key: 23620054
• Report Number: 2020813-2025-00010
• Device Sequence Number: 13273087
• Product Code: BSZ
• UDI-Device Identifier: 00813830023510
• UDI-Public: (01)00813830023510
• 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): 11/21/2025

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: 56800
• Device Catalogue Number: 56800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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