MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC
|
Back to Search Results |
|
Model Number 9734060 |
Device Problems
Human-Device Interface Problem (2949); Temperature Problem (3022)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 05/28/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Other relevant device(s) are: product id: 9660651, serial/lot #: (b)(4).A medtronic representative went to the site to test and service the equipment.The navigation system passed the system checkout and performed as intended.The axiem unit was returned to medtronic for evaluation.The axiem was connected to a test system for twenty eight hours and all ports tracked consistently throughout the duration of testing.The reported issue was unable to be replicated.There was no failure found with the returned axiem unit.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding a navigation device.It was reported that when setting up the system, the axiem box booted to a fault light after being connected to the navigation system.There was no patient present when this issue was observed.A medtronic representative (rep) later reported that he was on site and noted that the axiem controller continued to show the fault light after being powered on for a couple of minutes.Upon further review of the emitter details, the rep saw that the details showed "high temperature" errors.The rep was able to confirm that the failure was with the controller and not the emitter as he was able to borrow a secondary axiem controller to use it with the original emitter and it did not have an issue.
|
|
Search Alerts/Recalls
|
|
|