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

Model Number	EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the x7-8t tee transducer would not articulate during use with an epiq 7c ultrasound system.There was no patient or user harm associated with this event.The exam was completed without delay.The field service engineer replaced the transducer to resolve the issue.An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
Additional Manufacturer Narrative
A thorough investigation was to be performed to determine the cause of the reported problem.The issue was confirmed, and the philip¿s service engineer replaced the transducer to resolve the issue.The suspect part could not be obtained for further failure analysis.The system has returned to service with no similar issues reported.
Event or Problem Description
It was reported by the customer that the x7-8t tee transducer would not articulate during use with an epiq 7c ultrasound system.There was no patient or user harm associated with this event.The exam was completed without delay.The field service engineer replaced the transducer to resolve the issue.
Additional Manufacturer Narrative
It was previously reported x7-8t tee transducer would not articulate during use with an epiq 7c ultrasound system and the suspect part could not be obtained for further failure analysis.However, the part was returned at a later date and a thorough investigation was performed by engineering.The investigation found that the transducer articulates as expected with no issues when rotating the anterior/posterior and lateral/medial knobs.Additionally, the rotational function driven by the switch is functioning correctly.The investigation was unable to reproduce the described failure mode and has not identified any additional concerns with the mechanical articulation of the transducer.

• Brand Name: EPIQ 7C
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20826682
• Report Number: 3019216-2024-000164
• Device Sequence Number: 9806730
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: (01)00884838097872
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/04/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/11/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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