No patient involvement.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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It was reported that a centrimag console displayed a "motor failure" error message.The customer returned the motor and console for investigation.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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