Class I Recall of Arkon Anesthesia Delivery System
Spacelabs Healthcare has recalled the Arkon Anesthesia Delivery System due to the system going into a "failed state," where the mechanical ventilation function stops working, while the machine is in use, or while idle. The firm has not identified the reason for the failed state. When the machine goes into a failed state, a buzzer sounds, and an error image appear on the display monitor (see recall notice for photo of error image.) During the failed state, the anesthesiologist cannot access mechanical ventilation or monitor ventilation, which could increase the risk of patient injury. Emergency oxygen, vaporized agent delivery, and manual ventilation are still available.
To date, the firm has not received any reports of malfunctions, injuries, or deaths. However, continued use of this product may cause serious adverse health consequences, including death.
The U.S. Food and Drug Administration has classified this as a Class I Recall.
Recalled Product Details:
- Name: Arkon Anesthesia Delivery System
- Product code: CBK
- Model Number: 99999
- Manufacturing Dates: September 21, 2012 to September 28, 2017
- Distribution Dates: October 1, 2012 to October 6, 2017
- Devices Recalled in the U.S.: 253 units/li>
Spacelabs Healthcare sent an Urgent Medical Device Correction to hospitals and facilities with Arkon Anesthesia Delivery Systems with the following instructions:
- Weigh the benefits versus the risks when deciding whether to continue to use the Arkon Anesthesia Delivery System until it can be updated.
- If you continue to use the Arkon Delivery System, note that:
- The failed state can be cleared by powering down and restarting the system (which takes less than 2 minutes).
- Arkon is designed to allow for the continued delivery of manual ventilation, control of oxygen, and delivery of anesthetic agents in a power failure scenario. Clinicians can use emergency oxygen and manually ventilate the patient, providing gas and agent.
- Fresh gas flow automatically continues at the last set emergency oxygen value.
A Spacelabs representative will contact facilities to schedule a convenient time to update your Arkon Anesthesia Delivery System(s) at no cost. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Follow the link below for additional information.
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