Device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to a previous repair.Visual inspection found the device with peeled back switch label, worn line cord, float switch, cracked reservoir cover around the bolts and enclosure underneath the drain fitting.Paint chippings found internally/externally.Old style components include the printed circuit board and drain fitting.There was no evidence of the reported error in the event history log (ehl).The reported problem was duplicated/verified during functional testing.The crack on the enclosure was visible confirming the customer complaint.The cause of the issue was related to a cracked enclosure; the investigation was unable to determine who or what caused it.No action was taken due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.The root cause was unknown.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|