As per a manufacturer incident report we received from the factory in (b)(6): the "optitherm" accessory, which was intended for preheating the gas to be insufflated has overheated far beyond the intended alarm limit value of 41 °c.This situation was not detected by the main unit.This circumstance was not detected by the main unit, so no alarm was triggered.Due to the direct skin contact, a large burn corresponding to the size of the housing burn occurred.Two devices were involved (optitherm and thermoflator).This report is for device 2 (thermoflator).(mfr's.Internal complaint #(b)(4)).
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Since the devices were locked by the customer, a physical investigation could not be performed.Based on the investigation report (dated (b)(6) 2021), the most probable root cause is a defect of the heat exchanger.It is probable that the plug of the gas heater was twisted due to mechanical stress, which could have led to the reported failure.If a physical investigation is possible, a revised report will be submitted.
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