The electronic device logfile was available for investigation.Unfortunately, the user section was already overwritten as well as the device log records prior to 11:32am (it was reported the case took place between 10:42am and 11:40am).Thus, a reconstruction of the case in question was not possible.According to the device log, at 11:48am, 3:39pm and 7:23pm minute volume leaks of 0.5 to 0.7 l/min were measured indicating the presence of an external leakage in the patient circuit.No further relevant entries were recorded for the date in question.The evaluation revealed no indications for a technical malfunction.In case an external leakage is present prior to use, it will be detected during the power-on self-test as well as during the leak-test.During use, an external leakage will be alarmed accordingly.In general, the apollo is equipped with an integrated pressure-, volume- and patient gas monitoring that ensures that deviations from set/expected parameters are obvious and will be alarmed depending on the limits adjusted by the user.Finally, no indications for a device malfunction were found.As the user also did not allege a device malfunction to be in causal connection to the reported injury and as there are no hints for an inappropriate user handling in connection with the device, the case was assessed as not reportable and should not have been reported, if known before.
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