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

Model Number 51975-AUS

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Apnea (1720)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to accutron and is currently under evaluation.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.Per the user facility report, this was the first use of the device subject of the event.The instruction's for use include the instructions for testing the unit prior to first use to ensure proper operation.This testing would identify any issues with the functioning of the flowmeter prior to first use.The digital ultra flowmeter user manual states (3), "cautions safety features contained in this notice should be routinely checked to assure proper function.If any of these safety features are not functioning properly, contact your dealer or crosstex and arrange for the necessary repairs before reusing the machine." the user manual further states (24), "oxygen failsafe / crossed line test check prior to first use, when meter is moved, or monthly.Set flow to 8 lpm total flow and 50% n2o and then shut off all oxygen cylinders.Unit should go into oxygen failure alarm and n2o flow should stop.Note: this may take a few minutes for large central systems to use up gas in o2 passages.If gas continues to flow, n2o gas may be coming in on oxygen lines or circuit board could be damaged.Discontinue use immediately and contact crosstex as patients could suffer severe injury.".

Event Description

The user facility reported via vigilance report to tga that apnoea occurred during a patient procedure involving the digital ultra flowmeter.The patient required first aid treatment and the effects were reported to be temporary.

Manufacturer Narrative

The unit subject of the reported event was returned to accutron for evaluation.An in-depth investigation was conducted and determined that the unit's oxygen sensor wire disconnected from the oxygen flow sensor due to excessive stress on the internal cables.As the oxygen sensor wire was disconnected, the failsafe could not detect the presence of oxygen being delivered to the patient.This issue would be identified during the oxygen failsafe test that users are instructed to perform prior to first use to be able to identify that the machine is not working as intended and should be sent for repair.In the event associated with this issue, it was confirmed that this was the first use of the digital ultra flowmeter after installation, and that the user facility did not test the unit for proper operation prior to first use as instructed in the user manual.The user manual states: (2), "warnings verify that the correct gases are being delivered to the correct flowmeter inlets by performing the oxygen failsafe test in section vii." (23), "important safety features contained in this notice should be routinely checked to assure proper function.If any of these safety features are not functioning properly, contact your dealer or crosstex and arrange for the necessary repairs before reusing the machine." (24), "oxygen failsafe / crossed line test check prior to first use, when meter is moved, or monthly set flow to 81pm total flow and 50% n2o and then shut off all oxygen cylinders.Unit should go into oxygen failure alarm and n2o flow should stop.If gas continues to flow, n2o gas may be coming in on oxygen lines or circuit board could be damaged.Discontinue use immediately and contact crosstex as patients could suffer severe injury." additionally, it is important to note that patients should always be closely monitored during nitrous oxide use.The user manual states: (23), "training - the intended use is the basis for training which is considered mandatory for all operators prior to use.Requirements may be different between countries so check local regulations prior to performing nitrous oxide procedures." (2), "warnings 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." the customer will be provided a replacement unit.A review of complaints indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: DIGITAL ULTRA 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 ; 1733 west parkside ln.; phoenix, AZ 85027 ; 4403927453
• MDR Report Key: 16794632
• MDR Text Key: 313811578
• Report Number: 2020813-2023-00002
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830025040
• UDI-Public: 00813830025040
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 51975-AUS
• Device Catalogue Number: 51975-AUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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