RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Operating System Becomes Nonfunctional (2996)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2020.Date of this report: 06 oct 2020.
|
|
Event Description
|
The customer reported that the touch screen is unresponsive.The customer reported that the unit was not in use on patient.The customer contacted product support and requested for repair quote.
|
|
Manufacturer Narrative
|
G4: 01oct2020 b4: (b)(6) 2020 the field service engineer (fse) replaced the touchscreen to resolve the issue.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: 23sep2020 b4: (b)(6) 2020 per biomedical engineer it was confirmed that there was no allegation of touchscreen malfunction or failure.The touchscreen was replaced per the recall number z-1152-2020 & z-1153-2020.This report was inadvertently reported.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
|
|
|