G4: (b)(6) 2020.B4: (b)(6) 2021.Per authorized service personnel (asp) the issue was discovered during setting up for patient use.No delay in therapy was reported.The authorized service personnel (asp) tested the unit and found the ventilator monitors low tidal volume and will not go on standby.The authorized service personnel (asp) replaced the flow sensor assembly.After replacing the flow sensor the unit works and function correctly.A similar investigation was performed it was identified that the root cause was identified to be the component u1 designator on the o2 or airflow sensor printed circuit board assembly (pcba).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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