No patient involvement.The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
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It was reported that the centrimag primary console and centrimag motor were having issues.Audible and visual motor disconnected alarms were occurring.The account communicated that the rpm's would not exceed 3800 rpm's.The device was not in use on a patient at the time of the event.This event was previously not reported due to no patient involvement.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
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