Device Problems
Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no known patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).Livanova initiated an 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 received a report about sever occasions of alarm during priming.There is no evidence of patient involvement.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the facility to investigate the device and the issue could be confirmed.A loan device was provided to the customer.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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See initial report.
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Search Alerts/Recalls
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