Class I - Dangerous
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
CardioQuip
Class I - Dangerous
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Class I - Dangerous
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Class I - Dangerous
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class I - Dangerous
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.