MAUDE Adverse Event Report: LABORIES URODYNAMICS DUET MACHINE; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number URODYNAMICS DUET MACHINE

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

The healthcare provider (hep) requested support for the urodynamics "duet" machine as it was giving them the error code 00011 and not working properly.The event occurred on (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: URODYNAMICS DUET MACHINE
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIES
• MDR Report Key: 17529746
• MDR Text Key: 321384874
• Report Number: MW5136670
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: URODYNAMICS DUET MACHINE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1