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

Model Number	EPIQ 5G
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554); Insufficient Information (4580)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the user felt the sensations as tingling and shooting pain in the arm lasting approximately 5-10 seconds when using the l12-5 transducer.The l12-5 transducer was associated with an epiq 5g ultrasound system.The user was evaluated and received unspecified medical treatment.The customer confirmed that the symptoms are a direct result of the use of the transducer.The treatment and associated diagnosis were unspecified.Philips has started an investigation, and upon completion, a follow-up report will be submitted.

• 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: ondrea bermudez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 50900342
• Report Number: 3019216-2026-100323
• Device Sequence Number: 20296733
• Product Code: IYN
• UDI-Device Identifier: 00884838107502
• UDI-Public: (01)00884838107502
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Catalogue Number: 795204
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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