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

Model Number 27076

Device Problem Intermittent Loss of Power (4016)

Patient Problem Oversedation (1990)

Event Date 09/10/2020

Event Type  Injury  

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 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
• 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: 10649509
• MDR Text Key: 210423444
• Report Number: 2020813-2020-00001
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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