The reported field event of sparking was not confirmed in the laboratory.
The device was tested on the bench and no anomalies were found.
Abbott conducted a review of complaint files under a non-product capa and identified that a report was required to be filed as a result of the subject event.
Distributed devices are not affected by the capa.
Additionally, no new risks were identified, and no product-related actions are required as a result of this report submission.
Furthermore, product performance trending is not impacted by this report, and no new mitigation actions are required as a result of this report.
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