Model Number 16-02-80 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.The heater-cooler 16-02-80 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: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported error message.However during evaluation of the device it was found that the float assembly was bent.This issue could be determined as root cause for the incorrect displayed values.The service representative replaced the float assembly to resolve the reported malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.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 message and it was found that the level indicator was showing incorrect values during the device user maintenance.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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A bent float assembly can lead to two scenarios: either the sensor is stuck on the low position when the tank is full; then the h/c cannot be started as it believes there is no water or the sensor is stuck on the upper position but the tank is empty, water does not flow and an error would be triggered because the motor would not encounter the resistance of the water which was the situation with this complaint.Hence, the floater issue would always be detected prior to use and therefore was retrospectively considered not to be reportable.
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Search Alerts/Recalls
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