Model Number 25-28-69 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number has not been provided.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Livanova (b)(4) has requested the device for further evaluation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a s5 gas blender system did not deliver a stable oxygen flow during a procedure.The blood appeared dark and the pao2 and svo2 were both observed to be low at different points during the procedure.There was no report of patient injury.
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Manufacturer Narrative
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Serial number was received.(b)(4).As the serial number is known the udi could be retrieved.(b)(4).As the serial number is known the manufacturing date could be evaluated.(03.08.2015) through follow-up communication livanova (b)(4) was informed that the customer will not send the device back for further evaluation.Therefore no further investigation can be performed.As the issue could not be reproduced or confirmed, a root cause was not identified.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Search Alerts/Recalls
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