Model Number POLESTAR |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.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 outside of a procedure, the navigation system did not respond to prompt from the user.It was noted that an error message appeared stating that the api to gantry motion controller was not operating as designed.A site biomedical engineer was reported to have checked the connections and indicators on the navigation system without resolution.There was no patient present when this issue was identified.No additional information was provided.
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Manufacturer Narrative
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Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.It was found that suspected system components are either the s.P.S.Or the motion controller.Replacement of the component has not been performed as the site has not provided confirmation to medtronic to perform the replacement.
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Search Alerts/Recalls
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