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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their x8-2t transducer had articulation issues during clinical use.The customer was unable to use the transducer, so another device was used to complete the exam.A probe replacement was shipped to the customer to resolve their immediate concerns.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
The customer¿s immediate concerns were addressed by replacing the transducer.A thorough investigation was performed to determine the cause of the reported problem.The investigation found the transducer is capable of articulating in all four directions and meets the minimum angle requirements.The reported problem has not reoccurred at the customer site 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23487347
• Report Number: 3019216-2025-000424
• Device Sequence Number: 10488411
• Product Code: IYN
• UDI-Device Identifier: 00884838123960
• UDI-Public: (01)00884838123960
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 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: 10/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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