The provided information was used for the analysis.It was described that the device suddenly shut down and restarted twice.A software controlled restart of the whole electronic system is executed in case the device detects a deviation within the electronic system.The pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.This system restart is combined with an audible and visible alarm of high priority.If the failure is removed by this restart the device continues ventilation with the last settings.The device was repaired by a third party by replacing the power supply.No further issues were reported.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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It was reported that during use on patient the device suddenly occurred shut down and restarted, and the restart reoccurred after running several minutes.The hospital checked the main power was stable, the problem could be on the power supply unit.No patient injury reported.
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