Model Number 16-02-85 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.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 (b)(4) received a report that a heater-cooler system 3t displayed an error code and then shutdown during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10: through follow-up communication with the biomedical technician of the hospital livanova learned that the device was working properly and that the issue was due to an user error.The device in use and functional at the customer site and no service activity will be performed.Based on collected information, reportability decision changes to not reportable event since no serious injury occurred, the device is fully functional at customer facility and reported issue being caused solely by an user error.
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Event Description
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See initial report.
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Search Alerts/Recalls
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