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	Cardiac Arrest (1762)
Date of Event	04/16/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the epiq cvxi ultrasound system became unresponsive and locked up during an examination where a patient was coding.The clinician had to bring in another system in an attempt to complete the examination.Unfortunately, the patient did not recover from the code and ultimately expired; however, the customer has clearly stated the ultrasound did not cause the patient incident.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A philips field service engineer evaluated the system onsite to try and determine the cause of the ultrasound system lockup.During the inspection, the system passed all diagnostic, functional and electrical safety tests.Philips engineering performed a thorough review of system log files and found one instance of an informational message entry indicating possible foreign debris or moisture detected in the connector port of the system or transducer.The ultrasound system and transducer continue to be in use, with no further issues reported.Discussion with the director of cardiovascular non-invasive imaging at the site provided a summary of the event.The patient had multiple comorbidities and was a high-risk surgical patient for a urological surgery.After completion of the surgery during awakening from general anesthesia the patient went into extremis.They coded the patient.The hospitals standard procedure during a code is to perform a tee to evaluate heart function and rule out pericardial effusion.Cpr was continuing during this time.The patient passed away from a heart attack after 30 minutes.The cardiovascular director stated that the ultrasound machine did not cause or contribute to the death.The surgeon and anesthesiologist both agreed that the delay for the tee would not have changed the course of care.

• 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: 21971899
• Report Number: 3019216-2025-000189
• Device Sequence Number: 15579298
• Product Code: IYN
• UDI-Device Identifier: 00884838114142
• UDI-Public: (01)00884838114142
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Male