Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor.Visual examination of the mass flow sensor, as received, revealed the filaments to be burned.The reported "middle hot wire between pins are melted" failure was confirmed.The failure analysis technician determined the root cause to be due to material fatigue.This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life.Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor.Visual examination of the mass flow sensor, as received, revealed the filaments to be burned.The reported "middle hot wire between pins are melted" failure was confirmed.The failure analysis technician determined the root cause to be due to material fatigue.This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life.Upon further risk assessment, there is no danger of patient harm or user harm at the time of the filament failure as the hot wires are contained inside the plastic sensor housing and do not come in contact with the end user or patient at any time during use.Therefore the initial mdr should have not been submitted.This failure is unlikely to cause harm or injury to a patient or user.
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