It was reported, that "the patient was hypotensive, was in tot pcv mechanical ventilation mode, exhibits pcr in resp being resuscitated for 3 minutes.According to the doctor, the equipment does not present an error message and neither is it an alarm.On (b)(6) the patient died.".
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The dräger service report and the log file of the affected device were provided for the investigation.As the log file did not show alarm messages at the time of event ((b)(6) 2020, 00:31 a.M.), the investigation covered all log entries between the (b)(6) 2020, 01:47 a.M., when the device was switched off by the user.Based on this investigation a malfunction of the device without alarming could not be confirmed.There was no technical device failure found.The device performed ventilation without any device-caused disturbance and generated alarms based on the available monitoring according to its specification.Over the entire period of time as investigated the log file shows many alarm messages indicating a large leakage in the airway system.¿apnea¿-alarm was posted very often and several times the device switched over to apnea ventilation mode after the set time for the ¿apnea¿-alarm had expired in order to increase the expiratory flow.At the time of event the device was in apnea ventilation mode.Expiratory volume-related alarm messages could not be generated, as the expiratory flow monitoring had been set ¿off¿ on the (b)(6) 2020.Calculated volumes were thus not available for appropriate alarms, like ¿mv low¿.Positive airway pressure was available but no statement is possible about the gas volume that was administered into the patient and exhaled and how much gas was lost through the leakage.The instruction for use explicitly warns the user that without an expiratory flow monitoring, ventilation functions are restricted.Depending on the lung characteristics (resistance and compliance) a deactivated flow monitoring function may affect oxygenation of the patient and co2 elimination.Apart from those alarm messages indicating a leakage further entries were logged pointing toward a gas supply problem.However, no statement is possible whether the gas supply was disconnected intentionally in an attempt to remedy the problem with the leakage.The device reacted as specified and, as per log file, generated corresponding alarms to alert the user of the respective deviation.The technical investigation of the affected device performed on-site by dräger service also confirmed that the device had no technical failure including the audible alarms which also passed the test.
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