Model Number 397002-001 |
Device Problems
Mechanical Problem (1384); Device Inoperable (1663); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/03/2018 |
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 issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver has been 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 the companion 2 driver exhibited a left pressure incorrect alarm during a training session.
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Manufacturer Narrative
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The electronic patient data were reviewed and confirmed the customer-reported issue of multiple left pressure incorrect alarms during investigation testing, the left pressure incorrect alarms were reproduced and the root cause was determined to be a malfunction of the left electronic pressure regulator.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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