G4:15oct2020.B4:16oct2020.The device was sent to into the repair facility for further testing where the engineer evaluated the device and reported the flow rate was within specification.The reported problem could not be confirmed.The unit passed all testing in high flow and normal ventilation modes.No repairs on the unit are expected.Further review of the complaint indicated that the event was found during performance verification testing (pvt).There was no patient involvement.The pvt is pre-patient testing before the ventilator can be used on a patient.Therefore, any malfunction found during pvt will always be found and addressed before the ventilator can be put into service.Based on the information, the issue does not meet the reportability criteria.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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