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

Model Number 27076

Device Problem Insufficient Information (3190)

Patient Problem Oversedation (1990)

Event Date 11/11/2020

Event Type  Injury  

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 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
• Type of Device: FLOWMETER
• Manufacturer (Section D): ACCUTRON INC.; 1733 west parkside lane; pheonix AZ 85027
• Manufacturer (Section G): ACCUTRON INC.; 1733 west parkside lane; pheonix AZ 85027
• Manufacturer Contact: mitchell cole ; 9800 59th ave n; plymouth, MN 55442 ; 7638984338
• MDR Report Key: 10997532
• MDR Text Key: 221231593
• Report Number: 2020813-2020-00002
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: (01)00813830020885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other