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

Catalog Number	795231
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
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 reported their x8-2t transducer failed the electrical leakage test.The transducer was associated with the epic cvx ultrasound system at the customer¿s site.The issue was discovered outside of clinical use and 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 to be performed to determine the root cause of the reported failure.The suspect parts could not be obtained for further failure analysis.The system has returned to service with no similar issues reported.

• 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: 23405888
• Report Number: 3019216-2025-000396
• Device Sequence Number: 4927895
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: (01)00884838088658
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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 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: 12/05/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2020
• 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