RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Improper Flow or Infusion (2954); Output Problem (3005)
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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: 11sep2019.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The fse replaced the air/oxygen sensor assembly.The device passed performance verification testing following repairs.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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It was reported that the unit had a patient disconnect alarm message and the air flow reading was out of specification.There was no patient involvement.
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Search Alerts/Recalls
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