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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Shock (2072)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the l12-3 transducer delivered a light zap to a patient.The transducer was associated with an epiq elite ultrasound system.There was no patient or user harm associated with this event.A replacement transducer was shipped directly to the customer to address their immediate concerns.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
The transducer was replaced at the customer site to address their immediate concerns.The transducer could not be obtained for return for further failure analysis.The system has returned to service with no similar issues reported post repair.In addition, a review was performed dating back to january 2020, which identified zero other incidents in which an l12-3 transducer produced a spark or shock.There is no further information expected to be received for this incident.

• Brand Name: EPIQ ELITE
• 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: 23392889
• Report Number: 3019216-2025-000391
• Device Sequence Number: 18628335
• Product Code: IYN
• UDI-Device Identifier: 00884838107540
• UDI-Public: (01)00884838107540
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200304
• 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): 12/04/2025

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 Model Number: EPIQ ELITE ULTRASOUND SYSTEM
• Device Catalogue Number: 795234
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 11/20/2023
• 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