RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Device Alarm System (1012)
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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: 13sep2019.This complaint has been reassessed as reportable per quality plan 1141977pl after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.The manufacture¿s field service engineer (fse) performed troubleshooting and confirmed the reported issue.The fse advised the customer of the bench process (sending the parts to the manufacturer¿s facility for servicing).The customer decided not to use the bench process and find an alternate resolution instead.The fse later followed up with the customer who then indicated the issue had been resolved.
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Event Description
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The customer reported that the unit alarmed with high pressure.The unit was in use while the reported incident occurred, but no patient or user harm was reported.
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Search Alerts/Recalls
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