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: 08/23/2019.The manufacturer¿s international service technician advised that replacement of the key's membrane and the main board are required to address the reported problem.Numerous attempts were made to obtain follow up information from the customer on the repair status of the device without success.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 reports during use and without activating the on/off key, the unit intermittently displays a screen asking if the unit should be shut down.It was reported that the device was in clinical use at the time of the reported event however, there was no patient harm.
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Search Alerts/Recalls
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