FDA alerts to Class I recall of Perseus A500 Anesthesia System due to potential for sudden shutdowns on battery power

According to the FDA, Draeger, Inc.’s March 10, 2024, recall of its Perseus A500 Anesthesia System has been identified as identified as Class I, the most serious type, because officials have determined that use of the devices put patients at risk for major injuries or death.

The corrective recall, updated on May 15, 2024, covers 3,713 Perseus A500 devices that were distributed across the U.S. from December 12, 2011, to February 29, 2024.

Designed to anesthetize adult and pediatric patients, as well as neonates, the Perseus A500 anesthesia workstation provides automatic and manual ventilation. It also facilitates spontaneous breathing and pressure-supported spontaneous breathing.

Equipped with “airway monitoring, gas measurement and device monitoring, oxygen blower (insufflation),” as well as a system that receives anesthetic gas, Perseus mixes pure oxygen and medical compressed air, or pure oxygen and nitrous oxide, in addition to other anesthetic agents, to create anesthesia. A patient is also able to receive ventilation via “a laryngeal mask, a breathing mask, or an endotracheal tube.” In the event of a surgery or a diagnostic procedure, the device allows for a patient to inhale anesthesia, receive ventilation, or experience both.

Officials took action following customer reports that described the internal backup battery of the device suddenly failing while under battery power and off the main power supply. In those instances, the failure of the battery would cause the device to abruptly turn off without prior warning or indication that the device was low on battery.

A sudden device shutdown may put patients at risk of insufficient ventilation (hypoventilation) or insufficient oxygen (hypoxia) if an alternative ventilation option has to be adopted. These risks may then put patients at further risk of a major injury or death.

While Draeger Inc. has been alerted to four incidents in connection to the problem, no injuries or deaths have been reported to date.

Those who are directly impacted by the recall have been identified as patients who use Perseus A500 to receive anesthesia, as well as the healthcare providers who administer anesthesia via procedures that use the system.

An Urgent Medical Device Recall Notice sent to Draeger Inc. customers on March 10, 2024 recommended the following:

  • Test all the batteries of the device
  • If a device fails a battery test, contact Draeger to arrange for replacement batteries
  • Complete the return the verification form sent along with the notice

Further questions about the recall should be directed to Michael A. Kelhart, the company’s Director of Quality, by emailing mike.kelhart@draeger.com or by calling 267-664-1131.

As the FDA continues to oversee the recall, healthcare professionals and consumers alike are advised to report any adverse reactions or issues associated with the device to the agency’s MedWatch program.


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