MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	989605408541
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their c10-3v transducer¿s scan head was damaged, resulting in exposed metal.The transducer was associated with the epiq 5 ultrasound system at the customer¿s site.There was no patient or user harm associated with this event.A philips service engineer initiated the replacement process to resolve the customer¿s immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A qualified philips service engineer reviewed the reported problem with the customer and the issue was confirmed.A replacement transducer was sent to the customer to resolve their immediate concern.An investigation was performed that included a visual analysis of the transducer and a review of repair and inspection data, which determined that the damages to the scan head resulted from accidental user damage.There was no indication of either non-conforming material and no indication of design anomaly requiring further action.

• Brand Name: EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM
• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 23709267
• Report Number: 3019216-2025-000459
• Device Sequence Number: 10673529
• Product Code: IYN
• UDI-Device Identifier: 00884838047686
• UDI-Public: (01)00884838047686
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 989605408541
• Device Catalogue Number: 795204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown