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

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the system was not available during a critical procedure.The epiq cvx ultrasound system shut down multiple times during an unspecified open-heart surgery.The transducer was exchanged to complete the procedure.There was no patient or user harm associated with this event.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.The customer¿s immediate concerns were addressed by replacing the transducer.The transducer was tested, which determined that the connection cable was faulty.The system has returned to service with no similar issues reported.

• 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: 21700902
• Report Number: 3019216-2025-000064
• Device Sequence Number: 7910074
• Product Code: IYN
• UDI-Device Identifier: 00884838114142
• UDI-Public: (01)00884838114142
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 07/10/2025

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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 03/07/2024
• 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
• Patient Sex: Unknown