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

Model Number 31975

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

Patient Problem Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

Accutron requested and received the unit subject of the event for evaluation.The unit was tested and was found to be operating according to specifications.The ultra pc% flowmeter user manual states (2), "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 mask 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.

Event Description

The user facility reported that during patient procedures involving the ultra pc % flowmeter, three patients woke up and began to vomit.No additional medical intervention was required.

• Brand Name: ULTRA PC% 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: 18049724
• MDR Text Key: 327278829
• Report Number: 2020813-2023-00004
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830021158
• UDI-Public: (01)00813830021158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970163
• 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: 11/01/2023

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: 31975
• Device Catalogue Number: 31975
• Device Lot Number: (10)2637971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2022
• 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