The company representative was able to confirm and replicate the reported event(s).To address the ¿laser issue,¿ the non-conforming core module was replaced.The non-conforming radio frequency identification (rfid) printed circuit board (pcb) was repaired, to resolve the ¿burnt smell.¿ the system was tested and found to meet product specifications.A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported ¿burnt smell¿ is attributed to nonconforming rfid pcb.The root cause of the reported event ¿laser issue¿ is attributed to nonconforming core module manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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