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 04/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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The reported depleted battery was verified in the field by medtronic service technician.The service technician ran the instrument until the batteries were charged.Further analysis found that the batteries were over five years old.The issue was resolved by replacing the batteries.Final testing was performed per specification.The device history record was reviewed to show that the instrument passed all in-process inspections and tests.No abnormalities were noted during the manufacture of this instrument.Batteries are to be replaced every four years per the preventive maintenance schedule.A review of complaint and service records for june 2012 to april 2017 associated with this instrument found no other instances of battery replacement.A review of complaints identified no current trends.
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Event Description
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Medtronic received information that during use of this 560 bio console instrument the instrument powered off and a hand crank was used until the instrument could be plugged into power source.The hand crank was again used during patient transport as there was not sufficient time allowed to recharge the batteries.There were no adverse patient effects associated with this event.
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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 after approximately 25 minutes of using this 560 bio-console instrument on battery power, the instrument displayed the battery charge symbol on the user interface.The instrument had been running at approximately 2000-2500 revolutions per minute (rpms) and powered off after approximately 30 minutes.The hand crank was used until the instrument could be plugged into a power source in the ambulance.The hand crank was again used during patient transport into the hospital as there was not sufficient time allowed to recharge the batteries.There were no adverse patient effects associated with this event.
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Search Alerts/Recalls
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