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.
|
|
Search Alerts/Recalls
|