RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Protective Measures Problem (3015)
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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) 2017.Date of report: 08july2019.The manufacturer¿s field service engineer (fse) confirmed the reported post 3.3v test fail issue.The manufacturer¿s field service engineer (fse) replaced the defective user interface board and lcd screen to address the reported problem.The unit successfully passed the required performance verification test.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 3.3v test fail error code.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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