Model Number NGP680300 |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/12/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).Information in section f provided by the manufacturer.The field service specialist (fss) visited customer site to inspect the unit.Fss confirmed the reported issue and replaced the programmed hard drive assembly to resolve the problem.Fss performed the field service checklist, which the system passed all functional tests and it was found to meet amo specifications.All pertinent information available to abbott medical optics has been submitted.Placeholder.
|
|
Event Description
|
The customer reported of the whitestar signature system freezing suddenly.The customer tried to reboot system sometimes, however, there was no gain.There was no patient involvement reported and no patient treatments delayed or cancelled.
|
|
Manufacturer Narrative
|
A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.All pertinent information available to abbott medical optics has been submitted.
|
|
Search Alerts/Recalls
|