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

Model Number	56800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Accutron has made multiple attempts to contact the user facility regarding the report of "patients reacting unusual to nitrous" however, the user facility has not responded.The digital ultra flowmeter subject of the reported event was sent back to accutron for evaluation.Evaluation results determined that no issues were noted with the function or operation of the device and the digital ultra flowmeter was found to be operating according to specification.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported that patients are "reacting unusual to nitrous".

• Brand Name: DIGITAL ULTRA FLUSHMOUNT PACKAGE H
• 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: 18418568
• Report Number: 2020813-2023-00007
• Device Sequence Number: 6883368
• Product Code: BSZ
• UDI-Device Identifier: 00813830023510
• UDI-Public: (01)00813830023510
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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
• Device Lot Number: (10)27013
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2019
• 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