RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Appropriate Term/Code Not Available (3191)
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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: 04sep2019.The service engineer (se) was dispatched to site and confirmed the issue.The se inspected the device and found a leak from the o2 sensor set up.The se tightened the o2 sensor and resolved the leak within the customers circuit.The se performed performance verification and all test passed.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 ventilator was alarming a patient disconnect.There was no patient involvement.
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Search Alerts/Recalls
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