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

Model Number	989605488741
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transesophageal x8-2t transducer¿s sealant on the tip was coming off.The transducer was associated with the epiq 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.The philips service engineer replaced the transducer to address the customer¿s immediate concern.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed that determined the customer's reported issue was not reproducible.There was no indication of design defect nor a failure to meet manufacturing requirements for this transducer.The transducer was replaced to address the customer's immediate concerns and the replacement transducer is in service with no further similar issues.
Additional Manufacturer Narrative
The transducer information was inadvertently entered as the primary product and the epiq cvx ultrasound system information as the secondary product in the initial report.Therefore, the system product name, serial number, udi, catalog and model number have been updated as the primary product.There is no change to investigation details and outcome.

• Brand Name: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23843766
• Report Number: 3019216-2025-000493
• Device Sequence Number: 9526786
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: (01)00884838088658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K251651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 989605488741
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/28/2026; 01/28/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/25/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown