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

Model Number 27076

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Loss of consciousness (2418)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure involving the accutron digital flushmount flowmeter, the patient began to vomit and became unresponsive.The procedure was stopped and medical interventions were administered.

Manufacturer Narrative

The patient subject of the event sought medical evaluation following the reported event.Following the event, the technician noted that gas appeared to continue to flow and the bag appeared to inflate after the flowmeter had been powered off.A new flowmeter unit will be installed at the user facility.The digital flushmount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide, using titration method.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o." the unit subject of the event is being returned to accutron.A follow up report will be submitted with information regarding the unit condition and evaluation upon receipt of the device.

Manufacturer Narrative

The unit was returned to accutron for evaluation.The evaluation found that an amplifier on the main circuit board was not operating properly resulting in the reported event.The cause of the failure of the component could not be determined.Possible causes of the failure include voltage spikes in facility power or mechanical shock (physical damage) from being dropped or impacted.The digital flushmount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide, using titration method.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed.The o2 flush button can be used to rapidly purge the lines of n2o.If patient does not show signs of quick recovery, remove nasal hood and treat with pure oxygen from either the o2 resuscitator fitting or an auxiliary oxygen tank using a demand valve, oxygen assisted manual resuscitator, or equivalent.Call for emergency assistance if rapid response is not achieved.".A review of complaints indicates this to be an isolated event.A new unit was installed at the user facility.No additional issues have been reported.

• Brand Name: DIGITAL ULTRA FLUSHMOUNT FLOWMETER
• Type of Device: 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 ; 9800 59th ave; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13426088
• MDR Text Key: 287530740
• Report Number: 2020813-2022-00002
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: 813830020885
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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