MAUDE Adverse Event Report: ACCUTRON INC. ULTRA DC FLOWMETER

Model Number	31980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Vomiting (2144)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility reported to (b)(6) that during two procedures, patients were on n20 / o2 less than 10 minutes before vomiting.Staff in the room were getting headaches.
Additional Manufacturer Narrative
Device was received and tested.Manufacturer could not duplicate reported problem.Evaluation of device did find the n20 diss fitting #24036 had some minor damage, but damage would not cause a leak.

• 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: stephanie wasielewski ; 1733 west parkside ln.; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 21039653
• Report Number: 2020813-2024-00004
• Device Sequence Number: 15361330
• Product Code: BSZ
• UDI-Device Identifier: 00813830021219
• UDI-Public: (01)00813830021219
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/30/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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