The responsible dräger service engineer could not confirm the reported issue during on-site checking.However, the evaluation of the log file confirms an issue with the ventilator (motor) on the date of event.In case the primus shuts down automatic ventilation, the device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.In this case, automatic ventilation is not possible.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The motor asm has brushes, ball bearing, commutator disk and a spindle which are affected from aging caused by wearing.The kollmorgen motor asm, that was installed in the objected device, has been designed for a durability of >10 years (5 hrs/day, 5 days/week, 52 weeks/year, 13000 hours).The involved motor is approx.11 years old and with the 14555 hours logged, the device reached approx.112% of the estimated working hours.The replacement of the affected motor asm by the dräger service engineer has already solved the problem, no patient consequences have reportedly occurred.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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