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.The customer notified cardioquip that a patient was involved during the malfunction but no information about the patient or impact on the patient was given.The customer notified cardioquip, that a patient was involved during the malfunction but no information about the patient or impact on the patient was given.Upon inspection of the device, cardioquip identified the power plug had melted causing the odor.The temperature differential error was a result of incorrectly calibrated temperature controller.The plug was replaced, the temperature controller was calibrated, the device passed final inspection, and is fully functional.
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