Model Number 10-88-60 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported error.A preliminary analysis of the pump serial read-out indicates a possible issue with the motor control board and the motor power amplifier board.Investigation is still ongoing.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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During the operation check of s5 system before the start of the case, a s5 mast roller pump did not rotate and did not operate even when the power was turned off and on.A motor control failure error message appeared on the display.There was no patient involvement.
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Manufacturer Narrative
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H.10: another pump was provided to the customer.The motor control board of the affected device was replaced to solve the problem.The pump will be returned to service.
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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: the root cause of the reported event was traced back to a defective motor control board.
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Event Description
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See initial report.
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Search Alerts/Recalls
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