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

Model Number	27076
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user facility reported that during use of the digital flushmount flowmeter with 3 pediatric patients, more nitrous oxide was released than intended, which resulted in the patients to feel ill, vomit, and in rare events, passing out.It was reported that the dentist provided a flush of oxygen to each patient and successfully reversed the symptoms and no further medical attention was required.Accutron received the flowmeter from the user facility for product analysis and testing indicated that this situation occurred due to fluctuation in the power supply output of the device.The negative spikes in the power supply output occurred intermittently during testing.Accutron 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 with 3 pediatric patients, more nitrous oxide was released than intended, which resulted in the patients to feel ill, vomit, and in rare events, passing out.

• Brand Name: FLOWMETER, DIGITAL FLUSHMOUNT
• Common Device Name: FLOWMETER
• Manufacturer (Section D): ACCUTRON INC.; 1733 west parkside lane; pheonix AZ 85027
• MDR Report Key: 10649509
• Report Number: 2020813-2020-00001
• Device Sequence Number: 2963686
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: (01)00813830020885
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/08/2020
• 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