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

Model Number	EPIQ CVX 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	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their epiq cvx ultrasound system locked up during cardiac surgery, and proceeded to lock up again after restarting the system.There was no patient or user harm associated with this event.A qualified field service engineer evaluated the system based on the customer¿s complaint and could not reproduce the issue.Log review indicated dirty connectors were found, so the transducer connector was cleaned to address the customer¿s immediate concern.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
The customer¿s immediate concerns were addressed by cleaning the connectors at the transducer connection points and ultimately replacing the acquisition module.A thorough investigation was performed to determine the cause of the reported problem.During evaluation of the suspect part, the reported failure was unable to be replicated and no trouble was found.The system has returned to service with no similar issues reported post repair.

• Brand Name: EPIQ CVX
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23776610
• Report Number: 3019216-2025-000484
• Device Sequence Number: 10170320
• Product Code: IYN
• UDI-Device Identifier: 00884838123960
• UDI-Public: (01)00884838123960
• 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): 01/30/2026

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 CVX DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795231
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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