April 17, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Safety Alert regarding the ARKON Anesthesia Delivery System, which has a software defect that may cause the system to stop working.
The system could also stop working if a cell phone or other device is plugged into its USB port for charging.
The ARKON Anesthesia System is used in hospitals and operating rooms to deliver oxygen, air, nitrous oxide, or anesthetic vapor to patients in a controlled manner. If it stops working, patients would require manual ventilation. This could lead to hypoxemia (low oxygen in the bloodstream), a life-threatening complication that could cause brain damage or even death. One adverse event report has been linked to the software defect.
The manufacturer, Spacelabs Healthcare, is in the process of notifying customers. The ARKON Anesthesia Systems were distributed between March 18, 2013 and June 17, 2013 to sixteen hospitals in North Carolina and South Carolina.
Recommendation
Spacelabs recommends that customers contact them to set up a service appointment to install a free software update. You can also contact the company at 1-800-522-7025 and select 2 for Technical Support.
If you must use the system before the software update is installed, Spacelabs warns:
- 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.
Do I have an ARKON Anesthesia System Lawsuit?
The Schmidt Firm, PLLC is currently accepting anesthesia system induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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