Final analysis found burn marks on the printed circuit board (pcb) and the ac power adapter which contributed to the field complaint of power up anomaly.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.
|