The affected device was analyzed by the hospital¿s technical department.The log file was not available for analysis.It was reported that the power supply was determined to be the root cause.The replacement corrected the issue and the faulty power supply was disposed of.In case of a power supply failure and ongoing ventilation would stop and the user would be alerted to this condition by an audible power failure alarm according to iec 60601-1-8 for at least 2 minutes.During power failure an emergency-breathing valve would open allowing for spontaneous breathing.Manual ventilation with an alternate device may be considered necessary.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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