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) 2018.Date of report: 08/26/2019.The customer declined repairs and will contact the manufacturer should they decide to pursue repairs at a later date.It is not indicated that the device was evaluated.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 system keeps on showing high pressure error code while the patient is connected.The device was in use at the time of the event; however, there was no patient harm.
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Search Alerts/Recalls
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