MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA DC FLOWMETER

Model Number 31980

Device Problem Insufficient Information (3190)

Patient Problem Vomiting (2144)

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The ultra dc flowmeter subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that during two patient procedures involving the ultra dc flowmeter the patients became "nauseous" and "unresponsive".The patients were discharged and reported to be fine.

• Brand Name: ULTRA DC 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: 19182230
• MDR Text Key: 341790999
• Report Number: 2020813-2024-00001
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830021219
• UDI-Public: 00813830021219
• 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: 04/25/2024

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: 31980
• Device Catalogue Number: 31980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/25/2024
• 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