The manufacturer received information from a third-party service center during the device evaluation that the circuit board was damaged.There was no patient harm or injury.During the evaluation of the device at the third party service center, the device was visually inspected, and no visible foam particles were observed.There was a cosmetic defect of damaged buttoms or upper enclosure and ui panel damage.The device was scrapped.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
|