RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Device Alarm System (1012); Failure to Zero (1683)
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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) 2017.Date of report: 08aug2019.The manufacturer's field service engineer (fse) was dispatched to the site and evaluated the unit.The customer reported there was no patient involvement.The fse replaced the gas delivery system (gds) and solenoid valve to resolve the reported issue.The gds was return for analysis.The root cause: the pressure sensor u7 on the data acquisition (da) board of the customer returned gds had developed an offset.This caused the pressure accuracy test to fail and the ¿machine pressure sensor auto zero failed¿ alarm to occur.Replacing u7 resolved the issue and the pressure accuracy 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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Customer reported that the unit has an error code message of machine pressure sensor auto zero failed.The customer reported there was no patient involvement.
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Search Alerts/Recalls
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