MAUDE Adverse Event Report: Philips Ultrasound, Inc EPIQ CVXI; system, imaging, pulsed doppler, ultrasonic

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the epiq cvxi ultrasound system froze with an error message during a tteer (transcatheter tricuspid edge-to-edge repair).The system required multiple reboots to clear the freezing, and an exchange of the ice catheter was made without resolving the problem.The procedure was completed by using a tee transducer instead of an ice catheter.There was no user or patient harm.Philips has started an investigation, and upon completion, a follow up report will be submitted.

• Brand Name: EPIQ CVXI
• Common Device Name: system, imaging, pulsed doppler, ultrasonic
• Manufacturer (Section D): Philips Ultrasound, Inc; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): Philips Ultrasound, Inc; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tabitha gibbs ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 50938400
• Report Number: 3019216-2026-100324
• Device Sequence Number: 13445472
• Product Code: IYN
• UDI-Device Identifier: 00884838123977
• UDI-Public: (01)00884838123977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown