Model Number 560BCS1 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/15/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product has not been received in medtronic service for analysis.Upon completion of the analysis and investigation, a supplemental report will be filed.
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Event Description
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Medtronic received information that during use of this bio console 560 instrument, the display screen went blank and the master power switch was shut off and back on to recover the display functionality.During the restart of the instrument, the flow revolution per minute (rpm) stopped and a hand crank was used to maintain flow.The instrument was changed out with a backup and there was no adverse patient effect.The instrument will be returned to medtronic service.
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Manufacturer Narrative
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Upon receipt at medtronic¿s service depot, analysis of the bio-console base unit determined that the instrument was functioning as expected.The display screen performance issues were not verified during analysis.A review of the device history record for this device confirmed that no anomalies were observed during manufacturing.A review of prior complaints and service records for this device found no previously reported issues with the system controller board or the power supply.A review of complaints identified no current trends.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use of this bio-console 560 instrument, the display screen went blank and the master power switch was shut off and back on to recover the display functionality.During the restart of the instrument the flow revolution per minute (rpm) stopped and a hand crank was used to maintain flow.The instrument was changed out with a backup and there was no adverse patient effect.
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Search Alerts/Recalls
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