RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Defective Alarm (1014); 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: 02aug2019.The customer stated they could not recall or confirm the details related to the report of nurse call not working therefore; ts was not able to resolve the reported issue.Ts was able to help the customer resolve the issue of leak test failed- high pressure by advising the customer to correct the pin alignment then perform required testing per the manual for data acquisition (da) printed circuit board (pcb) removal.Ts suspected that a sensor failure was causing the 110b proximal pressure sensor autozero failed issue and recommended replacement part numbers for resolution.Follow up attempts have been made to obtain additional information on resolution of the proximal pressure sensor autozero failed issue; with no response from the customer.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 the nurse call function was not working.During troubleshooting, technical support (ts) confirmed a leak test failed high pressure and a proximal pressure sensor autozero failure.There was no patient involvement.
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Search Alerts/Recalls
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