MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA DC FLOWMETER

Model Number	31980
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ultra dc flowmeter subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during two patient procedures involving the ultra dc flowmeter the patients became "nauseous" and "unresponsive".The patients were discharged and reported to be fine.
Additional Manufacturer Narrative
The ultra dc flowmeter (sn: (b)(6) subject of the reported event has not been returned for evaluation.

• Brand Name: ULTRA DC 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: daniel davy ; 1733 west parkside ln.; phoenix, AZ 85027 ; 4403927453
• MDR Report Key: 19182230
• Report Number: 2020813-2024-00001
• Device Sequence Number: 12570801
• Product Code: BSZ
• UDI-Device Identifier: 00813830021219
• UDI-Public: 00813830021219
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 31980
• Device Catalogue Number: 31980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown