RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
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) 2018.Date of report: 07aug2019.The manufacturer's field service engineer (fse) performed remote troubleshooting and recommended the customer swap solenoids 2&4 noting if error changes to 1108 or 1109 to replace solenoid 4.The customer replaced the data acquisition (da) pcba to address the issue.The data acquisition (da) pcba was tested and no failures were identified.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 ventilator experienced proximal pressure sensor autozero fail.There was no patient involvement.
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Search Alerts/Recalls
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