RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Failure to Zero (1683)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2018.Date of report: 06aug2019.(b)(4).The field service engineer (fse) was able to verify the reported problem.The fse replaced gas delivery system (gds) and blower assembly to address the reported issue.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
|
During evaluation of the unit, the field service engineer (fse) observed a pressure sensor auto zero failure error.The customer reported that the unit was in use on patient, but there was no patient harm reported.
|
|
Search Alerts/Recalls
|
|
|