No patient information was not involved with the event.The device returned for analysis(if this is true, if not indicate that the device did not return).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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The distributor (b)(4) received the centrimag motor from a non-contract customer.The motor failed during routine test, - no patient was involved.The suspect motor was returned to (b)(4) for analysis.This event was previously not reported due to no patient being involved with the event.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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