MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA PC% CABINET MOUNT FLOWMETER

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

Patient Problem Vomiting (2144)

Event Type  malfunction  

Event Description

The user facility reported that during two separate patient procedures involving the ultra pc% cabinet mount flowmeter, the patients became sick and began to vomit.Both of the patients recovered quickly without additional medical intervention required.

Manufacturer Narrative

The ultra pc% cabinet mount flowmeter was returned to accutron for evaluation and was found to be operating properly.No issues were noted and the unit was returned to the user facility.The ultra pc% cabinet mount flowmeter instructions for use states, "to be used only by a professional trained in the use of nitrous oxide.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." no additional issues have been reported.

• Brand Name: ULTRA PC% CABINET MOUNT 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: 14805524
• MDR Text Key: 297961800
• Report Number: 2020813-2022-00004
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/24/2022
• 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