G4: 28dec2020 b4: (b)(6) 2021 the field service engineer replaced the cpu pcba (central processing unit, printed circuit board assembly) board as a precaution.The ventilator was calibrated successfully and passed all required testing.A cpu pcba (central processing unit, printed circuit board assembly) was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the root cause was isolated to a failure of the ls1 component.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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