Catalog Number 397002-001 |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2016 |
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 has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).Initial.
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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 did not pass the system checkout.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.Review of the patient data file revealed multiple system check failures on record, which were determined to result from a low voltage in the driver's 9v battery.These findings confirmed the customer-reported issue.During investigation testing the system check failure was reproduced.Based upon the results of the functional evaluation, the root cause of the customer-reported system check failure was a malfunction of the 9v switch board assembly which contributed to premature depletion of the attached 9v battery.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 the companion 2 driver did not pass the system checkout.
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Search Alerts/Recalls
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