Model Number CSS CONSOLE |
Device Problems
Device Alarm System (1012); Device Operates Differently Than Expected (2913); Power Problem (3010)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reported that the css console's vacuum was not working properly.The customer also reported that when he tried to adjust the vacuum, the alarm panel shut down.The customer also reported that the alarm panel subsequently turned back on.The customer also reported that the patient was switched to the backup css console without adverse impact.This alleged failure mode poses a low risk to a patient because it would not prevent the css console from performing its life-sustaining functions.The css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
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Manufacturer Narrative
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The css console was returned to syncardia for evaluation.Visual and electrical inspection of the css console's power systems revealed that the backup power supply/battery charger was inoperable.All affected components were replaced and the console checkout successfully passed all functional testing.This alleged failure mode poses a low risk to the patient because it would not prevent the css console from performing its life-sustaining functions.Each tah controller on the css console has its own internal backup battery and power supply.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
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Event Description
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The customer reported that the css console's vacuum was not working properly.The customer also reported that when he tried to adjust the vacuum, the alarm panel shut down.The customer also reported that the alarm panel subsequently turned back on.The customer also reported that the patient was switched to the backup css console without adverse impact.
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Search Alerts/Recalls
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