RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Application Program Problem (2880)
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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: 09/13/2019.The field service engineer( fse) confirmed the reported problem.The fse replaced the front bezel to address the reported problem.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 parameters bounce around during setting changes.It is unknown whether the device was in clinical use at the time of the reported event, but there was no patient harm reported.
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Search Alerts/Recalls
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