Draeger Medical is recalling Oxylog 3000 Plus Emergency and Transport Ventilators after receiving reports that the device stopped ventilation because of a depleted battery, even after being re-connected to AC power. According to an FDA release, the ventilator may not automatically switch back to using AC power when it is plugged in and may continue using the battery until it is depleted, then stop providing ventilation. When this issue occurs, battery alarm messages “Charge int. battery” and “Int. battery discharged” will appear.
The FDA has identified this as a Class I recall, the most serious type. Use of these devices may cause serious injuries or death.
Draeger Medical has reported six complaints, no injuries, and no deaths related to this issue. Since June 12, 2023, 300 of these Draeger ventilators have been recalled in the United States.
What to Do
For Oxylog 3000 Plus Emergency and Transport Ventilators with part numbers 5704811 and 5704813 distributed between April 30, 2012 and June 13, 2022, the company recommends the following:
- Make sure that the battery is always removed and reinserted or replaced after an occurrence of the “No int. battery charging” alarm message without removing the device from main power supply.
- Ensure the correct switchover by disconnecting and then reconnecting the device to an AC main power supply before using the device on battery power. Indicator A should display a green light, and indicator B should display a green or yellow light.
- If indicator B displays a red light, you should disconnect and reconnect or replace the battery.
- Devices can continue to be used safely as long as the precautions and actions above are taken.
- Ensure that all users and maintenance personnel of the products within the organization are made aware of the recall notice.
According to the company, a local Draeger service representative will contact customers to arrange for a firmware update of the printed board assembly charger.
