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	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the epiq cvxi ultrasound system displayed an error code during surgery in the cath lab.The surgery was completed after an exchange of the ultrasound system.There was no patient or user harm associated with this event.The power regulator was replaced to address the customer¿s immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A qualified service engineer evaluated the system based on the customer complaint.The service engineer confirmed the reported problem of the system generating an error message.It was determined the cause was related to the power regulator pcb (printed circuit board).The board was replaced to address the customer's immediate concerns.The system was returned to service with no further similar events.The part was disposed of at the customer site.No further information is available.

• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 24188531
• Report Number: 3019216-2026-100018
• Device Sequence Number: 12778771
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: (01)00884838097940
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/01/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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