Model Number S7 |
Device Problems
No Display/Image (1183); Device Stops Intermittently (1599)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the monitor of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The monitor has not been received by the manufacturer for evaluation.
|
|
Event Description
|
A site representative reported that, while outside of a procedure, the monitor of the navigation system lost display functionality without prompt from the user.It was noted that functionality was restored without prompt from the user.There was no patient present when this issue was identified.No additional information was provided.
|
|
Manufacturer Narrative
|
Additional information: unique device identification (udi) and device manufacture date updated to proper value.
|
|
Manufacturer Narrative
|
The monitor for the navigation system was returned to the manufacturer for analysis.The monitor was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
|
|
Search Alerts/Recalls
|