Patient was not involved with this 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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A customer has returned a centrimag motor, because it failed during routine testing.The motor had an intermittent cable fault.The motor worked fine until slight side pressure was applied to the motor bodys cable exit.The motor then instantly stopped and ¿system fault¿ was displayed on the 1st generation console.The same fault occurred, no matter, which console it was connected to.The suspect unit was sent to (b)(4) for evaluation.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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