The involved device is not under dräger service contract.The hospital's biomed has submitted photos from the error logs of the device.It can be seen that the supervisor function of the software detected repeated instances of vacuum pressure errors.This vacuum pressure is needed to keep the diaphragm of the ventilator in place to avoid wrinkling during piston movement.If significant deviations are detected the software forces a shutdown of automatic ventilation to prevent from serious mechanical damages to the ventilator unit.This shutdown is accompanied by a corresponding alarm; manual ventilation and the monitoring functionalities remain available.The imaginable root causes for a vacuum pressure error are manifold: a puncture of the piston diaphragm, a leak in the assembly of the dedicated pneumatic circuit, leaks inside the pump, pump calibration error etc.This expertise was transmitted to the biomed who reportedly performed some intervention at the anesthesia workstation and get it back working.It is not exactly known which measure was the one that rectified the problem.Hence, a clear root cause cannot be assigned by dräger.It can however be concluded that the workstation responded as designed upon a deviation in one of the subsystems.There was no injury reported.Remark: in total, 3 occurrences of the sporadic ventilator failure were reported by the user facility.The mdrs 9611500-2020-00012, 9611500-2020-00013 and 9611500-2020-00014 reflect these.
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