The company field service engineer visited the hospital and investigated the anesthesia workstation.Although no issues were found, the patient cassette was preventively replaced and sent in for investigation together with the device logs.The returned patient cassette.The patient cassette functions as intended.According to the test log, a successful sco was performed just prior to the event.There is no recorded sco after the event.The internal log contains clinical alarms such as fio2: low, etco2: low, expiratory minute volume: low and the technical log contains technical alarms indicating issues with the pressure during the event.We have not been able to determine the root cause of the reported issues.(b)(4).Ref.Exemption #: e2018003.(b)(4).
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