Other, other text: h6: event problem and evaluation codes: updated.H10: manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found cracked enclosure and tank cover.Damaged power switch and printed circuit board (pcb).Functional testing found the connection between the pcb and power switch is damaged.The root cause of the reported issue was found to be customer damage from use of the power switch.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.This issue is being monitored via an internal capa which corrected this issue (pcb to power switch connection damage) with design improvement.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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