Unfortunately, neither the electronic device log file nor replaced parts were available for investigation.As reported, the ventilator asm was replaced by 3rd party.No further information could be provided.In case the fabius 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 more than 12 years old (device manufactured in 08/2008).The affected motor asm has already been replaced, 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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