Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact peron: (b)(4).The investigation into this matter consists of an evaluation of the received device logs only as no parts have been reported as replaced.The received logs confirm the reported issue with high fico2 readings.A successful sco was performed prior to the event indicating that no technical malfunctions were present.Alarms for high fico2 level were generated during ongoing patient treatment.The logs show further that the co2 absorber was replaced during the case and that the user also tried to rectify the issue by increasing the fresh gas flow and activate the o2 flush several times without success.The received trend log confirms the high fio2 readings.We have not been able to determine the true cause of the reported issues.
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