No service on the ventilator has been requested.The user facility performs service by themselves.Information about the current status of the ventilator has not been provided.Provided ventilator logs were reviewed.In the event log on the reported event date there are alarms for inspiratory flow overrange, peep low and check tubing.These alarms indicate a leakage in the patient breathing circuit.During the situation causing the alarms, the measured volume will be different than the set or expected volume.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.In the test log, there is no successfully passed pre-use check prior ventilation was started.A pre-use check should always be performed before connecting the ventilator to a patient.The user performed a successful pre-use check after the event, which included a passed internal leakage test with a test tube.This indicates that the leakage was in the patient breathing circuit and not in the ventilator.The cause of the reported inability to deliver breaths to the patient was most likely a leakage in the patient breathing circuit.The cause of the leakage has not been determined.There are no indications of a ventilator malfunction.Correction of the fields# d4, serial# and h4 device manufacture date was required.This is based on the internal evaluation.# d4 serial#: previous serial#: (b)(6).Corrected serial#: (b)(6).# h4 manufacture date: previous manufacture date: 06/16/2014.Corrected manufacture date: 05/27/2005.H3 other text: 4117.
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