RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Increase in Pressure (1491)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2018.Date of report: 13july2019.Although the customer reported to the manufacturer that the device was repaired by a third party, no additional information was made available to the manufacturer.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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Event Description
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The customer reported a ventilator with a over pressure condition.This event was reported to have occurred during clinical use.But, there was no allegation of harm associated with this report.The event date was not specified, estimate used.
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Search Alerts/Recalls
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