Model Number 28-95-80 |
Device Problems
Loss of Power (1475); Pumping Stopped (1503)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 an s5 control panel mrp lost power during priming.This power loss led to a stop of the mast roller pump.The customer restarted the s5 system to resolve the reported issue.However, the reported failure recurred when switching to another device.There was no patient involvement.
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Manufacturer Narrative
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The mast pump and processor board were returned to livanova (b)(4) for further investigation.The devices were intensively tested without finding malfunctions.The devices worked according to the specification.As the issue was not reproduced or confirmed, a root cause could not be identified.
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Search Alerts/Recalls
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