RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Data Problem (3196)
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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: 13sep2019.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.The customer replaced the cpu to resolve this issue.Failure investigation was unable to replicate failure.No fault was found.
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Event Description
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The customer reported that there is no clear error code in the event log, and the date is completely off.There was no patient involvement.
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Search Alerts/Recalls
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