Model Number NGP680300 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The field service specialist (fss) visited customer site and replaced the bottle hanger on the unit.Fss performed the field service checklist, which the system passed all functional tests and it was found to meet all amo specifications.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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The customer reported that bottle hanger was broken and needed to be replaced on the whitestar signature system.There was no patient involvement reported.
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Manufacturer Narrative
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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.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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