MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ CVXI; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ CVXI ULTRASOUND SYSTEM
Medical Device Problem Codes	Unexpected Shutdown (4019); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their epiq cvxi ultrasound system shut down three times during tavi heart surgery.The procedure was completed on the same system.There was no patient or user harm associated with this event.The acquisition module and power regulator were replaced to resolve the immediate issue.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed, and the issue was not able to be reproduced.The replacement of the acquisition module and power regulator resolved the immediate issue.The system has returned to service with no similar issues reported.

• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 21090443
• Report Number: 3019216-2025-000008
• Device Sequence Number: 15612533
• Product Code: IYN
• UDI-Device Identifier: 00884838123977
• UDI-Public: (01)00884838123977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 CVXI ULTRASOUND SYSTEM
• Device Catalogue Number: 795232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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