Catalog Number 8000.COM03 |
Device Problems
Output Problem (3005); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/25/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product will be returned for investigation.
|
|
Event Description
|
We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with >30 minutes.No actual patient harm occurred.
|
|
Manufacturer Narrative
|
The product has been returned for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.In regard to this event an eva power supply was returned for investigation.Investigation of the returned power supply did not reveal any anomalies.The power supply performed within the release specification.Therefore, the event cannot be attributed to a defect of the returned item.Please note that the investigation is being continued in order to event (if possible) establish a root cause for the reported.
|
|
Event Description
|
We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with 30 minutes.No actual patient harm occurred.
|
|
Manufacturer Narrative
|
In regard to this event an eva power supply was returned for investigation.Investigation of the returned power supply did not reveal any anomalies.The power supply performed within the release specification.Since the issue was solved by replacing the power supply, it is most likely that the error occurred due to an unintended use error or possibly an issue with the power supply on location.However this cannot be determined conclusively.Review of the complaint database indicated that no similar complaints have been logged on the eva surgical system subject to this complaint.Therefore, based upon the investigation performed, it was determined that the reported event cannot be attributed to a defect of the returned item or the eva surgical system subject to the event.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.No corrective or preventive actions will be implemented as a result of this incident.
|
|
Event Description
|
We have been informed that the or staff was setting up the machine and could not turn it on.General anesthesia was already administered.Due to the reported event surgery was prolonged with >30 minutes.No actual patient harm occurred.
|
|
Search Alerts/Recalls
|