RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problems
Defective Component (2292); Temperature Problem (3022)
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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: 08/22/2019.The manufacturer's field service engineer (fse) confirmed the reported problem.The fse replaced the touch user interface (tui) board and battery to resolve the reported issue.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 "post board over temp" and "indicator failure" error messages.It is unknown if the device was in use at the time of the event; however, there was no patient harm reported.
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Search Alerts/Recalls
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