Spacelabs Healthcare Ltd. recalled its ARKON Anesthesia Delivery System with Version 2.0 Software due to a software defect that may cause the system to stop working.
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.
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. Spacelabs Healthcare received one report related to the software defect.
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 users continue to use the ARKON Anesthesia System, the manufacturer recommends that users 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.
- Do not use the USB ports until after the 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 manufacturer recommends that users switch to emergency oxygen and manually ventilate the patient until such time as they can safely remove the system from patient use.
- If the power is cycled, the system will reboot in roughly three minutes and recover from the software anomaly and mechanical ventilation can continue.
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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe