There was no demand for a ventilator investigation, and no logs are provided.The subjected edi catheter was scrapped.Evaluation of data from the user facility constitutes investigation.Ventilator settings were reportedly a nava level of 2.0, peep level at 6 cm h2o, upper pressure limit of 40 cm h2o and an o2 concentration of 50%.There were no issues with inserting and positioning of the edi catheter and no repositioning of the edi catheter was at any point performed during the usage time.According to the attending physician reviewing the case, neither the ventilator nor the chosen ventilation mode caused the event of pneumothorax.A check of the material parameters for the subjected edi catheter showed that all parameters were within the specified limits during manufacturing.The product met the final release criteria.There were no non-conformities identified with the batch.There is no evidence to support a technical malfunction of the edi catheter or the ventilator system.The underlying cause of the reported event has not been conclusively determined but was most likely patient related.There are no indications of ventilator malfunction.H3 other text : 4117.
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