Complaint no: (b)(4).The homechoice (hc) device was returned and evaluated by the product analysis lab (pal).A review of the device history records revealed no issues that could have caused or contributed to the reported difficulty.The external/internal inspection was performed and the device passed, along with all of the electrical testing.The fluid volumetric accuracy test that was performed, had failed with the original piston foam.However, when a test article, piston foam, was installed, the device passed the accuracy confirmation testing.The original piston foam was removed and inspection revealed a deteriorated piston foam.The evaluation concluded that the cause of the failed fluid volume accuracy testing was the deteriorated piston foam.The piston foam was to be scrapped and the device was sent to service.Should additional relevant information become available, a follow-up report will be submitted.
|