RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Intermittent Continuity (1121)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: (b)(6) 2019.Date of report: 10june2019.A follow up report will be submitted once the evaluation is complete.
|
|
Event Description
|
It was reported that the unit experienced intermittent touchscreen failures that prevented the unit from shutting down.The device was in use at the time of the event; however, there was no patient harm.
|
|
Manufacturer Narrative
|
Date rec¿d by mfr : 09jul2019, date of report : 01aug2019.The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue.The fse replaced the touchscreen and the issue was resolved.The unit was returned to service.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
|
Date rec'd by mfr: 15aug2019.The touchscreen assembly was returned to the manufacturer for failure analysis.A visual inspection revealed no signs of damage or contamination.During testing, the reported failure could not be duplicated.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
|
|
|