RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Decrease in Pressure (1490)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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: 22july2019.Manufacturer's field service engineer (fse) found multiple pressure error codes in the diagnostic logs.Fse replaced the pollen filter and ultra fine filter.Fse also calibrated the unit to reset the pressure sensors.Unit was tested and returned to service.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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Customer contacted technical support (ts) stating unit would lose pressure while in use.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.
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Search Alerts/Recalls
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