“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. …The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.This defect may cause serious adverse health consequences, including hypoxemia and death.”
Stan Hamilton of SoftewareCPR comments:”For devices that must fail operational or risk a hazardous situation, such as this one, one should always be on the lookout for single faults that could result in an interruption of essential functionality. The safe state for these devices is generally to continue critical operations, and possibly generate an alarm or warning to resolve the fault. Isolating critical processing modules from peripheral functionality can be an important aspect to consider in achieving the desired safety model.”
Brian Pate of SoftwareCPR comments: “Have you considered various types of testing? This failure mode is a reminder that combinatorial testing is critically important with multi-featured software devices. Ensure that your module, integration, and system level testing have adequate diversity of test types particularly around risk controls and primary operating functions.”
SoftwareCPR can provide assessments of your risk mitigation and test strategy and provide valuable feedback to gain greater test effectiveness in the most efficient manner. Contact us today to discuss how we could help.
The full FDA notice is at the link provided.