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	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a customer¿s epiq cvxi ultrasound system shutdown multiple times during an unknown procedure in the cathlab.The system was rebooted multiple times in an attempt to regain functionality.The user decided to exchange the ultrasound system to complete the procedure.There was no patient or user harm associated with this event.The system¿s e-box and entire echonav components and cabling were replaced in the system 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 to determine the cause of the reported problem.The issue was confirmed onsite, and the philip¿s service engineer ultimately replaced the ebox and echonav cabling and components to resolve their immediate issue.The investigation confirmed no trouble was found with the returned e-box.However, the echonav cabling and components could not be obtained for further failure analysis.The system has returned to service with no similar issues reported post repair.
Additional Manufacturer Narrative
It was initially reported that the system shutdown multiple times, but further review indicates that the system froze or became unresponsive.As such, as a result, a correction report is being 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 21490227
• Report Number: 3019216-2025-000053
• Device Sequence Number: 8436178
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: (01)00884838097940
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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 DIAGNOSTIC 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: 11/15/2024
• Supplement Date Received by Manufacturer: 04/21/2025; 07/07/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/12/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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