FDA labels recall of Draeger emergency ventilator Class I

The FDA labeled a recall of the Draeger Medical Oxylog 3000 plus emergency and transport ventilator Class I, the most serious kind.

Draeger designed its Oxylog 3000 ventilator for people who require full or partial breathing assistance from a mechanical ventilator. Healthcare professionals use it during patient transport, either in an ambulance or aircraft. They also use it to move people using ventilators throughout the hospital and recovery room.

According to an FDA notice, Draeger recalled the ventilator after receiving reports that it stopped ventilation due to a depleted battery. This occurred even after reconnection to AC power. The ventilator may not automatically switch back to using AC power when plugged in. In this case, it may continue using the battery until depleted, before stopping ventilation.

The FDA said a battery alarm — “Charge int. battery” and “Int. battery discharged” — occurs with this issue. Stopped ventilation could cause difficulty breathing, lack of oxygen, slow heartbeat or a sudden stop of the heart. This may lead to other severe injuries or death.

Draeger reports six complaints, no injuries and no deaths related to the issue.

In the U.S., the recall affects 300 total Oxylog 3000 ventilators, part numbers 5704811 and 5704813. Draeger distributed affected devices between April 30, 2012, and June 13, 2022, having initiated the recall on June 12, 2023.

According to the FDA, Draeger sent affected customers an urgent medical device recall letter last month. The company recommended users make sure the battery is always removed and reinserted or replaced after the alarm message comes through. They should do so without removing the device from the main power supply.

Users should also ensure the correct switchover by disconnecting then reconnecting the device to an AC supply before using battery power. Device use can continue safely as long as users follow the recommended precautions and actions. MassDevice