RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problems
Failure to Charge (1085); Defective Component (2292)
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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: 26july2019.The manufacturer's field service engineer (fse) confirmed the reported issue.Multiple attempts were made to obtain repair information; however, there was no response.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 back-up battery does not charge.The problem with the ventilator is that battery does not charge, but in battery mode, the equipment works fine.There is an alarm indicating low battery because the bi-pap is not able to charge it.The problem seems to be a defect in the user interface board.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.
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Search Alerts/Recalls
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