Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #:(b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(6).No service on the ventilator has been requested by the user facility.The expiratory cassette was reportedly replaced but was not returned for investigation.Provided ventilator logs were reviewed.Due to continuous use, the registrations from event date are overwritten in the event log.The reported low o2 delivery cannot be confirmed.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.The ventilator passed pre-use checks prior and after the reported event date.The expiratory cassette replaced by the user is only a measuring device in the ventilator and it measures the expiratory flow.The expiratory cassette has no impact on either delivered o2 concentration or measured o2 concentration.Since the event log is overwritten and no parts were returned for investigation, the root cause of the reported low o2 delivery has not been determined.
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