RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Overheating of Device (1437)
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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: 17july2019.The manufacturer¿s international service technician confirmed the reported issue.No action has been made at this time.Customer has not responded to attempts to obtain information on the repair of this device.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 that the unit overheats and the expelled air is hot.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.
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Search Alerts/Recalls
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