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

Model Number	795234
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the epiq elite ultrasound system was not available during a critical ob (obstetrics) examination.The system displayed an error code three times indicating restart or shut down was needed after acquiring cinematic loops.The procedure was able to be completed after multiple reboots.There was no patient or user harm associated with this event.The philips service engineer advised the customer to wait 6-10 seconds after acquiring the cinematic loop before entering review, as a workaround, to address the customer¿s immediate concerns.A thorough investigation was performed to identify the cause of the reported issue.It was determined that the reported problem was software related.Any actions needed to resolve this issue will be considered for development and implemented in future software updates.

• Brand Name: EPIQ ELITE 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 22516814
• Report Number: 3019216-2025-000253
• Device Sequence Number: 8078793
• Product Code: IYN
• UDI-Device Identifier: 00884838124912
• UDI-Public: (01)00884838124912
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 07/16/2025

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: 795234
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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