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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the epiq elite ultrasound system was not available during a critical renal artery exam in the emergency department.The system crashed during the procedure and was unable to be recovered.Another system was used to complete the procedure.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 qualified field service engineer evaluated the system based on the customer complaint and confirmed the issue.Error logs were reviewed, diagnostic tests were run, and the patient database was deleted.The software was reloaded and customer settings were rebuilt according to product support engineering and application specialist¿s instruction to resolve the customer¿s immediate issue.The system was returned to use with no further issues reported.The engineering team performed a thorough investigation of the reported problem and identified a software anomaly when using a specific, uncommon workflow.

• Brand Name: EPIQ ELITE 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 22382563
• Report Number: 3019216-2025-000239
• Device Sequence Number: 9355090
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: (01)00884838099111
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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
• 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: 06/21/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown