MAUDE Adverse Event Report: EPIQ 7C; GENERAL ULTRASOUND IMAGING SYSTEM, LINE-POWERED

Model Number	EPIQ 7C DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Codes	Unexpected Shutdown (4019); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A customer reported encountering an incident where their epiq 7c ultrasound system became unresponsive during a mitra clip heart valve procedure.The system was restarted to successfully complete the procedure.The patient was not harmed as a result of the issue.
Event or Problem Description
A customer reported encountering an incident where their epiq 7c ultrasound system became unresponsive during a mitra clip heart valve procedure.The system was restarted to successfully complete the procedure.The patient was not harmed as a result of the issue.
Additional Manufacturer Narrative
A thorough technical investigation was performed including evaluation and analysis of system logs.The software engineering team was unable to reproduce the issue and the root cause of the reported event could not be determined.This issue has not recurred at the customer site.If the issue recurs, another complaint record will be generated to further investigate the problem.

• Brand Name: EPIQ 7C
• Common Device Name: GENERAL ULTRASOUND IMAGING SYSTEM, LINE-POWERED
• MDR Report Key: 11903597
• Report Number: 3019216-2021-10066
• Device Sequence Number: 19162881
• Product Code: IYN
• UDI-Device Identifier: 00884838069718
• UDI-Public: 00884838069718
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 7C DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• Device Lot Number: US618B1568
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/06/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2018
• 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