Model Number I7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.It was reported that the equipment and nav interface racks for the navigation system were replaced.In addition, the io hub was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.
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Event Description
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A site representative reported that, while in a cranial resection, the navigation system displayed that the localizer was not connected prior to patient registration.It was noted that the navigation system was unresponsive to prompts from the user when attempting to troubleshoot.Restarting the niu and racks restored functionality.There was a reported delay to the procedure of 5-10 minutes due to this issue.There was no reported impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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The suspected i/o hub and transceiver devices were returned to the manufacturer for analysis.The i/o hub was found to be fully functional with no problem found.The transceiver was tested with other returned components and was found to not display image from any of the three ports.The internal dvi splitter led was on but no image was displayed.The splitter was bypassed and they were able to display as image.It was also noted that port 3 was making a static sound when plugged in, and the usb power led was not on but they were able to track active and passive tools for over 24 hours.
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Manufacturer Narrative
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A software investigation was initiated to determine the probable root cause of the anomaly.The investigation found that the reported issue was unrelated to the software of the navigation system.
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Manufacturer Narrative
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Patient info received.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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