Model Number 16-02-85 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2022 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to an eeprom failure (eeprom defective or cannot be accessed).There was no report of patient injury.
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in durango, colorado.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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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that: no service is required.The event was reported in error.It was customer mistake.Based on information received, reportability decision changes to not reportable event based on the fact that the issue did not occur and it was incorrectly reported by the customer and the complaint will be voided.
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Event Description
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See initial report.
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Search Alerts/Recalls
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