Pma/510k : 09dec2019, date of report: 30dec2019.After further investigation.This issue is not reportable.The air flow accuracy test is performed as part of the pvt (performance verification test), which is always performed prior to putting the ventilator into use on a patient.There is no risk of patient harm because the unit would not be put into use on a patient if it fails any portion of the pvt.This event is unlikely to cause or contribute to death or serious injury.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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