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

Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

A customer reported their epiq cvxi ultrasound system shut down in echo navigator mode during a mitra clip heart valve procedure.The procedure in progress was completed successfully without impacting patient outcome.The patient was not harmed as a result of the issue.

Manufacturer Narrative

Evaluation of the system logs and workflow will be included in a follow up report upon investigation completion.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue.However, the engineering team was unable to reproduce the failure.The field service engineer upgraded the system software to resolve the reported issue.

• Brand Name: EPIQ CVXI
• Type of Device: 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 13019319
• MDR Text Key: 282344520
• Report Number: 3019216-2021-10159
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• 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: 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
• Device Operator: Health Professional
• Device Model Number: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2019
• 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