Medical professionals and patients should be warned a potentially deadly bug in anesthesia machines. Problem can be found in version 2.0 of the AKRON anesthesia delivery system. When a device such as a phone is plugged into the anesthesia machine, it can cause lethal failure while delivering oxygen and/or medicine to surgical patients.
AKRON has issued a recall of the anesthesia system since it has USB but cannot perform life-saving duties if those ports are used. Currently, there are 16 known units in operation in North and South Carolina. As a necessary precaution, the FDA has issued a Class I advisory recall, the most serious since it’s now considered a dangerous medical device:
Reason for Recall: 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 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. There has been no injuries or deaths associated with this malfunction.
This is not AKRON’s first recalled medical product. The company’s BleaseSirius and BleaseFocus anesthesia workstations was another Class I recall that occurred last year. That recall was prompted by its insecure, defective software that made it easy for hackers to obtain personal data from patients.
Perhaps this is just another reason why Americans often complain about the cost of health care.