MalfunctionFEN
URODYNAMICS DUET MACHINE
Received Aug 12, 2023 · Event occurred Nov 17, 2021
Report MW5136670 · MDR key 17529746
Device
Product problems
- Device Displays Incorrect Message
- Output Problem
- Device Displays Incorrect Message
- Output Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
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).