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.A patient was involved during the malfunction of the device, no information was provided about patient outcome, but cardioquip was informed the patient was hypothermic after the device malfunctioned.During the investigation, cardioquip identified the heaters to be the source of the malfunction.The heaters distributed heat unevenly and caused the bushings to melt.Cardioquip also identified a external temperature controller and associated wiring to be nonfunctioning.All needed components were replaced and the device passed final inspection and is fully functional.
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