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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problems Failure to Power Up (1476); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

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 Description

A customer reported their epiq 7c ultrasound system failed to boot up properly and displayed an error message during a watchman mitral valve procedure.The system was used to replace another epiq unit during the procedure.The system was successfully rebooted and procedure was completed.There was no allegation of altered patient outcome as a result of the issue.

Event Description

A customer reported their epiq 7c ultrasound system failed to boot up properly and displayed an error message during a watchman mitral valve procedure.The system was used to replace another epiq unit during the procedure.The system was successfully rebooted and procedure was completed.There was no allegation of altered patient outcome as a result of the issue.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue.The investigation identified the failure as a software anomaly which has been addressed in a more recent software release.Communication has been provided to inform the customer of the software solution.The system was restarted to resolve customer¿s immediate concerns and no additional similar issues have been reported since this repair.

• Brand Name: EPIQ 7C
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 12125758
• MDR Text Key: 260468593
• Report Number: 3019216-2021-10084
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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
• Device Operator: 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
• Distributor Facility Aware Date: 06/08/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1