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

Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Output Problem (3005)

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

Event Date 08/13/2021

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.This evaluation involves system log and workflow analysis.

Event Description

A customer reported an epiq cvxi ultrasound system would not capture ecg waveforms during an interventional surgery.The procedure in progress was completed successfully after restarting the system.There was no patient or user harm associated with this event.

Event Description

A customer reported an epiq cvxi ultrasound system would not capture ecg waveforms during an interventional surgery.The procedure in progress was completed successfully after restarting the system.There was no patient or user harm associated with this event.

Manufacturer Narrative

A philips field service engineer went to the customer site to gather system data for further investigation.A thorough investigation was performed to identify the root cause of this issue, including an evaluation and analysis of the logs from the ultrasound system.The software engineering team concluded the customer was not using the correct settings and workflow to properly capture ecg waveforms.No system malfunction was identified during the system log review.The system has been placed back into service with no additional complaints regarding this issue reported by the customer post notification.

• 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: 12443394
• MDR Text Key: 270627098
• Report Number: 3019216-2021-10117
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Date FDA Received: 09/08/2021
• 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
• Distributor Facility Aware Date: 08/13/2021
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• 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