RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Device Displays Incorrect Message (2591)
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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: 26july2019.The manufacturer's field service engineer (fse) confirmed the reported issue.The manufacturer¿s field service engineer (fse) replaced the defective battery to address the reported problem.The unit successfully passed the required performance verification test.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 device displayed a battery faulty or missing error code.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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