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FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

Friday, April 18, 2014

ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop WorkingSerial numbers of units distributed in the U.S. 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

AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Managers, Nursing

ISSUE: Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software 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 cause the system to stop working.

This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.

BACKGROUND: The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The primary users of this device are qualified physicians.

RECOMMENDATION:  Spacelabs Field Service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue. Until the software updates are installed, Spacelabs Healthcare provided the following recommendations for health care facilities with ARKON 

Anesthesia Delivery Systems:

• If you continue to use your ARKON Anesthesia System, we recommend that you do NOT save spirometry loops until Spacelabs has remedied the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.

• Advise users NOT to use the USB ports until after your 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. We recommend that the user switch to emergency oxygen and manually ventilate the patient until such time as they can safely remove the system from patient use.

• If you cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.

For questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including links to the Recall Notice at: http://go.usa.gov/k8JA.

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