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

Model Number 56800-CHAIR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

The patient subject of the event sought medical evaluation following the reported event.The unit was removed from service.Accutron has requested that the unit subject of the reported event to be returned for evaluation.Our investigation into the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure involving the digital ultra flushmount flowmeter, the patients o2 saturation began to drop.The procedure was stopped and medical intervention was administered.

Manufacturer Narrative

The digital ultra flushmount flowmeter subject of reported event was returned for evaluation.No issues with the function or operation of the flowmeter were identified.The unit was confirmed to be operating according to specification; the reported event was unable to be duplicated.User facility personnel were counseled on the proper use and operation for the digital ultra flushmount flowmeter.The instructions for use states, 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." 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 ; 1733 west parkside ln.; phoenix, AZ 85027 ; 4403927453
• MDR Report Key: 18290959
• MDR Text Key: 330045116
• Report Number: 2020813-2023-00006
• Device Sequence Number: 1
• Product Code: BSZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 56800-CHAIR
• Device Catalogue Number: 56800-CHAIR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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