L
In order to protect the user, the medical device we designed has a inside temperature monitor. When the inside temperature is too high the device will automatically show an error message "temperature is too high" on the control screen and turn the device OFF. Then the users can not continue to do the treatment by the product at that moment.
Questions:
One user used our medical device. One day the user reported the devie showed the error message "temperature is too high". Should we regard this is device malfunction?
My understanding is if the device did not show error message to customer when the temperature is too high, then it is "MALFUNCTION"!!! But if it showed the error message, it is still functional (not malfunction).
I do not know my understanding is right or not?
Leon
Questions:
One user used our medical device. One day the user reported the devie showed the error message "temperature is too high". Should we regard this is device malfunction?
My understanding is if the device did not show error message to customer when the temperature is too high, then it is "MALFUNCTION"!!! But if it showed the error message, it is still functional (not malfunction).
I do not know my understanding is right or not?
Leon