The investigation was based on the reported event, correspondence and enhanced information.The logbook was sent later.The case was initially reported to the appropriate authorities because an adverse event with cause of death of a covid patient was notified.The analysis of the provided log file has shown that the ventilation was started on (b)(6) 2021 at 1:23 pm.On (b)(6) 2021 at 8:58 pm the device posted during the evening several alarm messages concerning "peep high" and "peep low".The user started several suction maneuvers at 9:07 pm, 10:47 pm, 11:27 pm, 11:35 pm and 11:43 pm.At 11:55 pm the user switched the device into standby mode.The log file confirmed peep related alarms on the date of event.A high peep could cause e.G.By the patient condition or obstructions in breathing circuit (blocked filter or fluid in breathing circuit).Fluid in breathing circuit corresponds with the several suction maneuvers which were performed on (b)(6) 2021.The device reacted like specified to a detected difference between the set and measured peep and posted accompanying alarm messages.The log file analysis did not reveal a device malfunction.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects high peep audible alarms would be posted to inform the user about the problem.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
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