Model Number 16-02-95 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-95 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).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 during procedure all the displays of a heater-cooler system 3t became black.It recovered after turning the power off and on several times.After that, it could be used without any problem, and the operation was completed.In addition, it was reported that an error was displayed before the display disappeared, but the error code could not be confirmed clearly.There was no report of 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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H10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The processor board and the display & keyboard were replaced and the problem could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root causes of the reported issue are related to false contacts issues or to defective boards.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned device serial number.The information has been added to the dedicated d.4 section as well as udi code.Manufacturing date of device has been accordingly added to the h.4 section.
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Event Description
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See initial report.
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Search Alerts/Recalls
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