RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Increase in Pressure (1491)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2019.Date of report: 01/03/2020.
|
|
Event Description
|
The customer reported high o2 (oxygen) pressure, and no o2 available.There was no patient involvement.
|
|
Manufacturer Narrative
|
G4: 15jan2020.B4: (b)(6).The manufacturer¿s field service engineer (fse) could not replicate the problem.Replaced all parts ordered.Performed full testing.All tests passed.No fault found.(est) extended self test passed.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.If parts are returned, the complaint will be reopened and an investigation will be performed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|
|
Manufacturer Narrative
|
G4: 25feb2020 b4: (b)(6)2020.The oxygen (o2) solenoid and daq board were returned to the manufacturer for failure investigation (fi).After testing, it was determined that the customer complaint was not verified.There was no fault found.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|
|
Search Alerts/Recalls
|
|
|