MAUDE Adverse Event Report: ACCUTRON INC. FLOWMETER, DIGITAL FLUSHMOUNT

Model Number	27076
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user facility reported that during use of the digital flushmount flowmeter, more nitrous oxide was released than intended, which resulted in the patient to feel nauseous.The reported event did not cause or contribute any serious injury or deterioration of health.This event could potentially lead to serious injury if it were to recur.The device was not returned to the manufacturer for investigation and therefore confirmation and root cause of the reported event could not be established.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that during use of the digital flushmount flowmeter, more nitrous oxide was released than intended, which resulted in the patient to feel nauseous.

• Brand Name: FLOWMETER, DIGITAL FLUSHMOUNT
• Common Device Name: FLOWMETER
• Manufacturer (Section D): ACCUTRON INC.; 1733 west parkside lane; pheonix AZ 85027
• MDR Report Key: 10997532
• Report Number: 2020813-2020-00002
• Device Sequence Number: 19719989
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: (01)00813830020885
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 27076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other