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

Model Number 27076

Device Problem Gas Output Problem (1266)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

The digital ultra flushmount flowmeter was returned to accutron for evaluation and was found to be operating properly.No issues were noted.Through follow-up testing with facility personnel, it was found that the user facility's nitrous and oxygen gas lines were set up incorrectly by the third-party plumbing contractor causing the wrong gas to be input into the flowmeter.The flowmeter was installed in (b)(6) 2022 and had only been used a few times prior to the reported event.The user facility should have performed the oxygen failsafe test prior to initial use of the flowmeter.The digital ultra flowmeter 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." 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." the user facility stated that they would contact the third-party plumbing contractor that installed the gas lines to address the issue prior to returning the flowmeter to service.Accutron counseled user facility personnel on the proper use and operation of the digital ultra flowmeter specifically performing proper start up testing including the oxygen failsafe test.No additional issues have been reported.

Event Description

The user facility reported that during two separate patient procedures involving the digital ultra flushmount flowmeter, one patient began to vomit and another became unresponsive.The patients were administered oxygen and fully recovered.

• 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 ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13981241
• MDR Text Key: 297963125
• Report Number: 2020813-2022-00003
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: 813830020885
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/01/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 27076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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