Model Number 397002-001 |
Device Problems
Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that during a demonstration session, the companion 2 driver did not display right pressure waveforms.The customer also reported that the driver did not pass a subsequent system check.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.Investigational testing determined the root cause of the customer-reported issue was a malfunction of the pressure sensor printed circuit assembly.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) follow-up report 1.
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Event Description
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The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that during a demonstration session, the companion 2 driver did not display right pressure waveforms.The customer also reported that the driver did not pass a subsequent system check.
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Search Alerts/Recalls
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