RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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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: 23aug2019.The manufacturer's field service engineer (fse) was dispatched to the site and evaluated the unit.The screen shell, membrane, filters and battery assembly were replaced to correct the issue.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 enclosure on the unit was cracked, required screen shell, membrane, filters and battery assembly.There was no patient involvement.
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Search Alerts/Recalls
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