The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning ARKON Anesthesia Delivery System with Version 2.0 Software, manufactured by Spacelabs Healthcare Ltd. The affected products were manufactured and distributed from 18 March 2013 through 17 June 2013. The affected serial numbers include ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

The manufacturer is recalling the affected products due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may also cause the system to stop working.

This defect may cause serious adverse health consequences, including hypoxemia and death. The manufacturer received one report related to the software defect. There has been no injuries or deaths associated with this malfunction.

The manufacturer will provide software update installation to the affected users to resolve this issue. Until the software updates are installed, the manufacturer provided the following recommendations for users of the affected products:

• If users continue to use the ARKON Anesthesia System, the manufacturer recommends users NOT to save spirometry loops until the manufacturer has remedied the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
• Users are advised NOT to use the USB ports until after the ARKON software is updated.
• If the error does occur, the user will hear a buzzer and a warning icon will appear on the main display screen. The user should switch to emergency oxygen and manually ventilate the patient until such time as users can safely remove the system from patient use.
• If users cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.

For details, please refer to FDA websites:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm393536.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 April 2014