G4: (b)(6) 2020.B4: (b)(6) 2020.H11: after further investigation.The ventilator failed the leak test, is a duplicate of pr 9930468, and is not reportable due to the following rationale: the leak 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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