Model Number 10-85-00 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(6) manufactures the s5 double head pump.The incident occurred in (b)(6), united states.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected part has been requested back for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report that on a s5 double head pump the speed cannot be adjusted.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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An analysis of the serial read-out of the pump has been performed and the issue could not be confirmed.Furthermore, investigation at the manufacturer site revealed that no deviations could be found and that the device was working within specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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