The device was checked by a dräger service engineer who performed an initial review of the log file and replaced the circuit board that controls the therapy functions as well as a memory (cf) card.The device passed all consecutive test and could be returned to use.A detailed log file analysis was provided by the manufacturer; the reported issue could be reconstructed.The ventilation of the concerned procedure went stable and uneventful in the beginning until the therapy control unit performed a reboot to overcome a deviation in the sw processing.The reboot was successfully completed after 12 seconds and, the device resumed ventilation with previous settings.The user completed the surgery without additional issues and, the device remained in use until the on-site check and preventive parts exchange was made.The root cause for the deviation in the sw processing could not be determined.The log did not contain further instances of this failure.Dräger finally concludes that the device responded as designed upon a deviation of unknown origin; a reboot was initiated to set all sw processes back to a controlled state, the user was alerted to the reboot by means of a corresponding alarm and, therapy was continued afterwards with the latest valid settings.The parts that could be put in causal connection to the event have been replaced as a precautionary measure.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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