RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2019.Date of report: 10april2019.Manufacturer's field service engineer (fse) evaluated the unit and confirmed the reported issue.Fse replaced the unit's user interface (ui) pcba and battery to resolve the reported issue.Unit was tested and passed all testing.Unit ready for service.
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Event Description
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Customer contacted technical support (ts) stating that unit had error message of power on self test (post) board over temp.Issue occurred at power on.No patient involvement.No patient harm or injury reported.Event date not specified, estimate used.
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Search Alerts/Recalls
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