RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Output below Specifications (3004)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Date of report: 13aug2019.The customer contacted product support and troubleshoot the issue and was verified proximal sensor reads 3.1 cmh2o with a set point of 10 cmh2o.Product support recommended to customer to check seating and lubrication of sensors.Product support provided part number & price for data acquisition pcb.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.
|
|
Event Description
|
The customer reported that the proximal line pressure is reading low.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|