Model Number 9733560XOM |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that hardware needed to be replaced.The computer was replaced and the system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the system became unresponsive.The mouse would still move, but they could not click on anything.A hard shut down was performed and when the system came back up it would not boot past the booting kernel screen.Another hard shut down was performed and when trying to turn it back on the system only showed "no input detected".There was no delay as the system was switched out for a different system and the surgeon was using non-navigated instrument during the swap.A field service engineer (fse) went to the site to troubleshoot and noted that they were able to boot the system up but as they were in the ent application it froze.A hard shut down was performed and the computer changed out.There was no impact to the patient outcome.
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Manufacturer Narrative
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Analysis found no fault with computer.The computer booted normally to the application screen.The ent and dicom programs ran normally and no freezing was observed during burn-in testing.There were no errors from the seatools long test or the memtest86 and the computer passed phd testing.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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