Model Number BI-700-00027-120 |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2018 |
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.The representative reported that a surgeon at the site had driven the imaging system into a x-ray viewer box.It was reported that after manual adjustment of the door locks restored functionality to the imaging system.The imaging system then passed the system checkout and was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.
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Event Description
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A medtronic representative reported that, while in a procedure, the gantry door of the imaging system was unable to close entirely.It was reported that the imaging system was restarted 3 times, along with manual adjustment of the interface (umbilical) cable, restored functionality.It was reported that the pendant displayed that the door was open when the gantry door was closed.It was noted that a "clicking" noise emitted from the imaging system.There was no known impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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Additional information: the reported issue occurred in a lumbar posterior spinal fusion.It was noted that there was a 90 degree kink in the interface (umbilical) cable that did not allow the imaging system to operate.A second medtronic imaging system was brought into the operating room (or) to complete the procedure.There was a reported delay to the procedure of around half an hour due to this issue.Patient demographics provided.
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Search Alerts/Recalls
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