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

Model Number	EPIQ ELITE ULTRASOUND SYSTEM
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported having challenges with the 2d image quality in the calf veins; they alleged they could not distinguish a clotted vessel from a non-clotted one when using the epiq elite ultrasound system.Although there was no misdiagnosis as the patient had a prior exam to compare, they could not diagnose properly based on the study.There was no allegation of patient/user harm, injury, or death.An investigation is underway to determine the root cause of the issue.A follow-up report will be provided upon investigation completion.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The customer¿s immediate concerns were addressed by adjusting the customer¿s transducer presets.The investigation found that the product is working as designed.The system has returned to service with no similar issues reported.

• 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: 21324160
• Report Number: 3019216-2025-000029
• Device Sequence Number: 7917586
• Product Code: IYN
• UDI-Device Identifier: 00884838099111
• UDI-Public: (01)00884838099111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 01/10/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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