Model Number 10-85-00 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 double head pump.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 deutschland received a report that a s5 double head pump stopped during procedure.Customer was able to turn it off and on.There was no patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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Through follow up with the livanova field service engineer it was clarified the present event is a duplicate of the mfr report number 9611109-2023-00519.Present case is being voided and follow up will be submitted through mfr report number 9611109-2023-00519.
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Search Alerts/Recalls
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