MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Discomfort (2330)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received an nmpa#(b)(4).It was reported a customer¿s epiq 7c ultrasound system, in use with an x7-2t transducer, was not available due to a system lock up.The system was exchanged, but the transducer could not be used and required a replacement as well.The patient experienced throat discomfort and emotional excitement.The patient's blood pressure increased to an unspecified level.The patient required reassurance along with information regarding the transducer replacement.The customer alleges a serious injury occurred, however there is insufficient information regarding the patient outcome at this time.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
This was initially reported for an allegation of a serious injury.However, additional information was received that verified there was no actual serious injury associated with this event.The routine tee echocardiogram was able to be completed.It was clarified the patient did not feel any throat discomfort.The emotional tension caused the patient's blood pressure to increase to an unspecified level but did not require any medical intervention or affect the outcome.The reported problem indicated in this event is not likely to cause or contribute to a serious injury or death if it were to reoccur.

• Brand Name: EPIQ 7
• 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: 23547039
• Report Number: 3019216-2025-000433
• Device Sequence Number: 13123899
• Product Code: IYN
• UDI-Device Identifier: 00884838109995
• UDI-Public: (01)00884838109995
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 07/24/2023
• 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