Federal safety officials have determined that a recall issued last month for an ARKON anesthesia delivery systems should be categorized as a Class I Medical Device Recall, due to the potential risk that continued use of the machines may carry a risk of serious and potentially life-threatening outcomes for patients.
The ARKON anesthesia delivery system recall was originally initiated on March 10, but was upgraded to a Class I recall by the U.S. Food and Drug Administration (FDA) on April 16. Software on the anesthesia machine may be defective and cause the device to shut down during use, posing a loss of ventilation to patients. To date there has been at least one report of the software malfunctioning, but no injuries or deaths have been reported.
The Spacelabs ARKON Anesthesia Delivery Systems are devices used by qualified physicians in hospitals for the delivery of oxygen, anesthetic vapor, and nitrous oxide in a controlled manner to patients for various surgical procedures. The machines are also equipped with a mechanical ventilator.
The FDA has upgraded the safety concern of the recall due to defective software that may cause the delivery systems to shut down during use and require manual ventilation of patients. In addition to random shut downs, the machines may also stop working if a cell phone or USB device is plugged into one of the four USB ports. If the machine shuts off during use, it may cause the patient to suffer serious adverse health consequences, including hypoxemia and death.
The recall includes the Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System’s with version 2.0 software that have and of the following serial numbers; 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.
The systems were manufactured and distributed by Spacelabs Healthcare Ltd., of Hertfordshire, United Kingdom from March 18, 2013 through June 7, 2013. The FDA is aware of at least 16 units distributed to hospitals in North and South Carolina.
Spacelabs Healthcare sent all registered customers an Urgent Medical Device Correction letter on March 11, identifying the problems and the course of action to be taken to fix the software. Customers should contact Spacelabs Healthcare’s Field Service Personnel at 1-800-522-7025and select 2 for technical support.
Until the software correction is complete, Spacelabs has recommended physicians not save spiromentry loops because a combination of this and waveform changes may cause a shutdown. If the shutdown error does occur, the user will notice an error icon on the monitor and hear a warning buzzer. If this occurs users are recommended to switch to emergency O2 and manually ventilate the patient. Customers are also encouraged to not use the USB ports.
Class I recalls are considered the most serious, and mean that the FDA has determined there is a reasonable probability that the use of the product will cause serious adverse health consequences, such as severe injury or death.
This is the second recall of a SpaceLabs anesthesia system in less than a year. In October 2013, the company issued a recall for the BleaseSirius and BleaseFocus Anesthesia Workstations due to a defect that could cause the units to fail to provide proper ventilation. The FDA classified that as a Class I recall as well.