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 was notified by the customer that there was patient involvement during the malfunction, although no information identifying the patient was provided.Upon initial investigation, cardioquip discovered the heater chamber was melted where it contacts the heater and heater bushing.The device passed inspection and is fully operational following replacement of the damaged components.
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