Physio-Control LifePak CR-Plus AEDs. The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Posted 9/14/2009 FDA Link
