The local dräger s&s organization has performed an on-site evaluation of the patient monitor and the central monitoring station.The patient monitor had a mechanical damage of the housing and was equipped with a non-dräger internal battery which was defective or did otherwise not allow operation without mains supply.Besides these non-conformities, monitoring was functional.The logs for the particular monitoring episode had been overwritten already since the device remained in further use.The logs of the central monitoring station had been erased as well.In general, the reported aspect of delayed alarming can neither be confirmed nor denied due to the fact that the information relevant for an assessment was not available.There is however no indication for the potential presence of a device malfunction.The non-conformities observed with the device should have prevented from putting it into use, but these have no relation to the reported event; monitoring was functional when the device was tested in follow-up of the event.Another aspect that substantiates the postulation that no device-related errors have likely occurred during the course of event is that the device was further used afterwards - an operator would probably not do this when significant concerns against the safety and performance of the device exist.A reliable conclusion in regard to the exact root cause for the reported event cannot be made.A number of contributing factors must be taken into consideration while - on the other hand - a differentiation is not possible due to lack of information.For example, if a sensor for a particular monitoring channel becomes detached from the patient (ecg electrodes, spo2 sensor), the device will post a technical alarm.It is in the nature of things that life-threatening conditions which occur in sensor-off condition cannot be detected anymore via this channel; the device will not post physiological alarms.It would also be plausible that a loss of network connection has interrupted the forwarding of alarms to the central station while the alarm posted by the bedside monitor was recognized with delay only.
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