RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problems
Unintended Power Up (1162); Self-Activation or Keying (1557)
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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: 11april2019.Manufacturer's field service engineer (fse) evaluated unit and confirmed the reported issue.Fse found unit power cycled after five (5) minutes.Fse also found case cracked.Fse replaced the unit's user interface pcba, battery, and case assembly to resolve the reported issue.Fse reloaded system software and ran system calibration.All testing passed.Unit ready for service.
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Event Description
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Customer contacted technical support (ts) stating that unit powers on by itself.The customer reported there was no patient involvement.Event date not specified, estimate used.
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Search Alerts/Recalls
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