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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer was reported that the epiq cvx ultrasound system shut down during an unspecified cardiology operation.Additional information to determine the type of procedure and patient outcome is being gathered.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
No further information was able to be gathered to determine the type of procedure and patient outcome.A thorough investigation was performed to identify the cause of the reported issue.The reported problem could not be reproduced with the information able to be obtained.The system has returned to service with no similar issues reported.
Additional Manufacturer Narrative
Additional information was received by the site¿s remote service engineer, and it was confirmed the issue occurred during start up and no patients were impacted.

• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23308720
• Report Number: 3019216-2025-000363
• Device Sequence Number: 5814248
• Product Code: IYN
• UDI-Device Identifier: 00884838123960
• UDI-Public: (01)00884838123960
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/15/2026

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: 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 01/09/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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