The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.Cardioquip inspected the device and identified the main heater threads had been cross threaded into the chamber.This caused the leak and overheating issue.Cardioquip replaced the components and device passed final inspection and is fully functional.
|