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	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the epiq 7c ultrasound system was not available during a critical procedure.During an unspecified open-heart surgery, the system was displaying poor quality images.The user exchanged the transducer a few times and then exchanged the system.The procedure was able to be completed with no patient or user harm.The biomedical engineering reported that the issue was resolved by reseating the power regulator and the acb board.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was to be performed to determine the cause of the reported problem.The issue was confirmed by the customer site biomedical engineer, who reseated the power regulator and the acb board to resolve the customer¿s immediate concerns.The service engineer evaluated the system and concluded that the issue was resolved.There were no parts replaced and therefore, no part evaluation was completed.The system has returned to service with no similar issues reported.

• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20370203
• Report Number: 3019216-2024-00141
• Device Sequence Number: 6859781
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: (01)00884838097872
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2014
• 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