MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the transducer port shocked the user while connecting/disconnecting the transducer to the epiq 7 ultrasound system.The system was not in clinical use at the and there was no reported serious injury associated with this event.The philips service engineer performed hardware tests and inspected all transducer cables and power cable for any damage and none was found.The acquisition module was replaced as a precautionary measure to address the customer¿s immediate concerns.Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Additional Manufacturer Narrative
An investigation was performed to determine the cause of the reported problem.The replaced acquisition module was returned for evaluation, and the reported problem was unable to be reproduced.However, the sonographer stated she was wearing gloves with gel on her fingertip when removing the transducer which may have contributed to the light shock sensation and was advised to keep water-based products away from the ports when connecting and disconnecting the transducer.The system has returned to service with no similar issues reported.

• Brand Name: EPIQ 7
• 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: 23904813
• Report Number: 3019216-2025-000503
• Device Sequence Number: 12684085
• Product Code: IYN
• UDI-Device Identifier: 00884838097865
• UDI-Public: (01)00884838097865
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/25/2026

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 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795200
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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