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

Model Number 27076

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Accutron has made multiple attempts to contact the user facility regarding the report of "patients reacting unusual to nitrous" however, the user facility has not responded.The digital ultra flowmeter subject of the reported event was sent back to accutron for evaluation.Evaluation results determined that no issues were noted with the function or operation of the device and the digital ultra flowmeter was found to be operating according to specification.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

Event Description

The user facility reported that patients are "reacting unusual to nitrous".

• 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: 18418568
• MDR Text Key: 331599932
• Report Number: 2020813-2023-00007
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: 00813830020885
• 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
• Report Date: 12/29/2023

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: 27076
• Device Catalogue Number: 27076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2019
• 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