Model Number 16-02-85 |
Device Problem
Loss of Power (1475)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective ac board.The technician replaced the board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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.Evaluated on site by livanova rep.
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Event Description
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Livanova (b)(4) received a report that a heater-cooler system 3t spontaneously shuts off during procedure.There was no report of patient injury.
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Manufacturer Narrative
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The defective board was returned for further investigation.During the evaluation it was found that high current on the fixed voltage regulator caused high impedance state on resistors r2 and r3.However it could not be determined how the high current was caused.
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Event Description
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See initial.
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Search Alerts/Recalls
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