Model Number BI-700-00027-120 |
Device Problems
Mechanical Problem (1384); 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 01/30/2018 |
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.A medtronic representative went to the site to test the equipment.It was reported that the keyboard for the viewing station of the imaging system was replaced.The imaging system then passed the system checkout and 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 medtronic representative reported that, while performing a planned maintenance (pm), the keyboard of the imaging system was missing an arrow key.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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Review of this event and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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