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Model Number 560BCS1 |
Device Problems
Device Alarm System (1012); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2024 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation:the reported black screen on the main display and a faults error code on the small screen was verified during service.The service technician found that the ui was black and there was no output of back light pcb on ui.The issue was resolved by replacing the ub-assy ui 560 bioconsole.Preventative maintenance was performed per specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that during use of a bio-console instrument, it was reported that there was a black screen on the main display and there was a faults error code on the small screen.The motor could run normally, the flow rate was displayed.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that all electrical connections were normal while the bio-console was powered off.The hand crank was required to maintain flow while the instrument was replaced.
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Search Alerts/Recalls
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