MAUDE Adverse Event Report: Philips Ultrasound, Inc EPIQ 5G; system, imaging, pulsed doppler, ultrasonic

Model Number	EPIQ 5G Ultrasound System
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury

• Brand Name: EPIQ 5G
• 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: tabitha gibbs ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 50952445
• Report Number: 3019216-2026-100326
• Device Sequence Number: 9499416
• Product Code: IYN
• UDI-Device Identifier: 00884838047686
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EPIQ 5G Ultrasound System
• Device Catalogue Number: 795204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 12/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown