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and functional testing was performed.Visual inspection found cracked enclosure and tank cover, faded line cord, outdated printed circuit board (pcb) and power switch.Functional testing found the device leaked from a crack near the drain tube confirming the customer complaint.The root cause of the reported issue was found to be wear and tear damage from repeated use of the drain tube.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: d4: model num.
|