Model Number 48-40-00 |
Device Problem
No Audible Alarm (1019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.The field service representative replaced the motor end stage board hmf 0408 and subsequent functional verification testing found no further issues.The issue was solved and the device was returned to service.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.
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Event Description
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Livanova (b)(4) received a report that rotating the pump rotor manually in the direction opposite to the operational one when a s5 roller pump was off, no alarm sounded.This was identified by a livanova field service representative during maintenance.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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H.10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.The part was requested for further investigation at the manufacturer site.Results revealed that the buzzer on the motor power amplifier was not working therefore no alarm sound was emitted.
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Search Alerts/Recalls
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